MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number	FGS-0347
Medical Device Problem Codes	Failure to Transmit Record (1521); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
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 patient mentioned that the recorder was flashing yellow after a bowel movement.They reported four hours into the study.The patient was unsure if the capsule was passed.A copy of the study was sent in for review and evaluation and the study duration was three hours and 51 minutes.The full small bowel was captured and there were no issues with the study.They are going to acquire an x-ray to confirm if the capsule has been passed.There was no reported patient outcome.
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, gfh files was provided by the customer for analysis.The returned sample met specification as received by medtronic.The customer reported that the patient mentioned that the recorder was flashing yellow after a bowel movement.They reported four hours into the study.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.The investigation identified the cause of the reported event to be tested satisfactorily.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 8377701
• Report Number: 9710107-2019-00071
• Device Sequence Number: 1332891
• Product Code: NEZ
• UDI-Device Identifier: 07290101362951
• UDI-Public: 07290101362951
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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 Number: FGS-0347
• Device Catalogue Number: FGS-0347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 05/12/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other