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Device Lab 15

MCCE

MCCE in the BMEssentia 3D Device Lab

A 100 mm by 100 mm N42 block on a six-axis manipulator. m squared of dipole moment and dissipates nothing at all.

Also called: Capsule Endoscopy, Magnetically Controlled Capsule. Arabic: كبسولة التنظير المغناطيسية. Device Lab 15 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Permanent-magnet manipulator

A 100 mm by 100 mm N42 block on a six-axis manipulator. m squared of dipole moment and dissipates nothing at all.

Electromagnet coil array

Eight water-cooled coils on a non-ferrous former around a 700 mm bore: two coaxial pairs and four saddle coils, 420 mm mean winding radius, driven by current amplifiers. The field can be commanded to zero and it goes.

How it works: the main parts

What each part does, from the MCCE lessons in the 3D Device Lab.

Field command console
The console is where a person asks this machine for something, and the first honest thing to notice about it is what it will not accept. There is no control here that asks for a pull of so many millinewtons.
Field solution and pose estimator
This unit is the one that answers the question nobody can measure: where is the capsule and what is it experiencing. It takes the commanded source geometry, the image, and the reference field reading, and produces a pose.
External permanent-magnet head
890 kilograms and consumes nothing. It produces its field the moment it exists and it will still be producing it when the building loses power, when the software crashes, and when everyone has gone home.
Six-axis manipulator
The manipulator is the only actuator in this configuration. The field source cannot be turned up or down, so every command the operator gives becomes a motion of six joints, and the quality of the control is the quality of the arm.
Keeper and parking enclosure
The keeper is the closest thing this configuration has to an off switch, and it is a steel can. Parked inside it, the head still produces its field; the difference is that the steel offers the flux a much easier path than the air outside, so what escapes into the room collapses.
Gravity-independent retract accumulator
An unswitchable source needs a way to leave the patient when the electricity does not. This cylinder is that way: a charged gas accumulator on the fore link whose only job is to drive the head clear without any power at all.
Capsule internal magnet
This is the smallest component in the device and everything else exists to talk to it. A cylinder of neodymium iron boron eight millimetres across and five long, sitting off-centre inside a swallowed shell, and its dipole moment is the entire interface between a person and a machine standing outside them.
Capsule shell
The shell is the boundary between a person and a machine, and it is the only part of this device that goes inside anybody. Eleven millimetres across, twenty-six long, and it has to hold a magnet, an optical head, two cells and a radio while being swallowable.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Entrapment of Device217
Device Operates Differently Than Expected26
Output Problem25
Human-Device Interface Problem22
Unintended Application Program Shut Down20
Failure to Transmit Record16

Raw counts of adverse event reports for this device type (FDA product code NEZ, QKZ), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.

Planned maintenance checks

From the BMEssentia procedure library: every 12 months, about 60 minutes, electrical class I, applied part type BF.

CheckPass when
Magnet unit, recorder and room
Inspect the magnet controller, the patient couch, the recorder and the field warning signs.
No damage; signs in place.
Electrical safety
Test to IEC 62353.
Within limits.
Motion and image link
Run the manufacturer's motion test and a test capsule image link.
Per manufacturer.

Test instruments: Manufacturer's capsule test tool; Gaussmeter (manufacturer's).

Recent FDA recalls

RecallProduct and reason
Z-2536-2020
2020-02-26
Capso Vision, Inc.: The CapsoCam Plus (SV-3)
Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. Root cause: Employee error.
Z-1827-2020
2019-10-18
Capso Vision, Inc.: CapsoCAM Plus, UDI: 00867770000209
Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Root cause: Other.
Z-2073-2020
2019-07-03
Capso Vision, Inc.: CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 -
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. Root cause: Process control.
Z-1615-2018
2017-02-15
IntroMedic Co., Ltd.: Miriam Capsule Endoscope System. Model MR1100
When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage. Root cause: Device Design.
Z-1748-2011
2011-03-23
Given Imaging Ltd.: Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers
The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval. Root cause: Device Design.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 6 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

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