MalfunctionNSI

PILLCAM

Received Feb 14, 2005 · Event occurred Nov 24, 2004

Report 575843 · MDR key 575843

Device

Generic name

Endoscopic Capsule Imager

Manufacturer

Given Imaging Inc

Model number

Catalog number

Lot number

Product problems

Device Issue

Patient

64 YR

Therapy/non-surgical treatment, aborted/stopped

Narrative

Description of Event or Problem

A CAPSULE ENDOSCOPY FAILED ON A QUADRIPLEGIC PATIENT. THIS WAS DUE TO CAPSULE FAILURE AS CONFIRMED BY GIVEN IMAGING, THE MANUFACTURER OF THE IMAGING CAPSULE. GIVEN IMAGING WAS ASKED IF IT WAS ADVISABLE TO DISCONTINUE USING THE CAPSULES OF THAT LOT. GIVEN IMAGING ADVISED THE HOSPITAL TO CONTINUE USING THE REST OF THE CAPSULES IN THAT LOT GROUP.