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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
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GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE Back to Search Results
Model Number FGS-0501
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/24/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, they had a patient who had a retained capsule.The physician made an inquiry regarding other doctors who could perform the removal of the capsule, because of the inability to perform a double-balloon enteroscopy.There was no reported patient outcome.
 
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Brand Name
PILLCAM
Common Device Name
SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
Manufacturer (Section D)
GIVEN IMAGING LTD., YOQNEAM
yetsira 13 street
yoqneam 20692
MDR Report Key8077950
Report Number9710107-2018-01053
Device Sequence Number1516599
Product Code NEZ
UDI-Device Identifier07290101364399
UDI-Public7290101364399
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K123864
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberFGS-0501
Device Catalogue NumberFGS-0501
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2018
Initial Report FDA Received Date11/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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