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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-0347
Medical Device Problem Codes Insufficient Device Problem Information (3190); Data Problem (3196)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/30/2019
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, the recorder prompted an error 62 message which meant that the sd card contributed to the failure of the data retrieval.The patient had to extend hospitalization for another day because of the repeat procedure.
 
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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
IL  20692
MDR Report Key9618617
Report Number9710107-2020-00035
Device Sequence Number2721227
Product Code NEZ
UDI-Device Identifier07290101362951
UDI-Public07290101362951
Combination Product (Y/N)N
Initial Reporter CountryHK
PMA/510(K) Number
K123864
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberFGS-0347
Device Catalogue NumberFGS-0347
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/30/2019
Initial Report FDA Received Date01/22/2020
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 Hospitalization;
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