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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD. PILLCAM PATENCY CAPSULE

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GIVEN IMAGING LTD. PILLCAM PATENCY CAPSULE Back to Search Results
Model Number PILLCAM PATENCY CAP
Event Type  Injury  
Event Description

As agile capsule was identified in the projection of the cecum 3 days after ingestion. The pt was asymptomatic at that time and received laxative treatment as preparation for pillcam sb capsule procedure. Then clinical development of the ileus started with abdominal pain and vomiting. In a ct performed the following day the capsule was still intact. Further the ct revealed a suspected longer stenosis throughout the terminal ileum with an appearance of a corresponding ileus of the small intestine. The capsule could still be located in the cecum directly near a clip which had been implanted endoscopically into the cecum. In a ct performed 4 days prior to the injection there were no pathological findings in the intestine. Abdominal x-rays had been performed in the next days. Three days later, the last x-ray located the intact capsule in the sigmoid colon. After intravenous application of a daily dose of 250mg prednisolone the ileus formed back quickly within three days. The pt had been released asymptomatically.

 
Manufacturer Narrative

Pillcam patency capsule is an accessory to the pillcam video capsule and its intended use is to verify adequate patency of the gastrointestinal tract prior to administration of the pillcam video capsule in pts with known or suspected strictures. Although we don't have info on whether the pt had a history of surgery and expected post-surgical adhesions, it is likely that the capsule was retained due to adhesions. Also such pathologies usually do not evolve in such a time frame.

 
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Brand NamePILLCAM PATENCY CAPSULE
Type of DevicePILLCAM PATENCY CAPSULE
Manufacturer (Section D)
GIVEN IMAGING LTD.
hermon bldg., new industrial park,
p.o. box 258
yokneam 2069 2
IS  20692
MDR Report Key3308450
Report Number9710107-2013-00218
Device Sequence Number1
Product CodeNEZ
Report Source Manufacturer
Source Type User facility
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/15/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPILLCAM PATENCY CAP
Device Catalogue NumberFGS-0109
Device LOT NumberNOT AVAILABLE
Was Device Available For Evaluation? No
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 08/14/2013 Patient Sequence Number: 1
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