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

Model Number	FGS-0497
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
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 had a hard time ingesting the capsule and it was stuck on the patient's throat.The patient conditional capsule passed normally.Files was transferred the over for review, the log files showed that the sensor was disconnected and the navigation was pressed during the duration of the procedure.The battery of the recorder was at 96%, and there was no equipment failure.There was no implanted devices or telemetry present.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: this report is based on information provided by medtronic investigation personnel and the sample that arrived.One bravo capsule and one bravo delivery device were received for evaluation.A review of the product expiration date discovered this product was used before the expiration date.The returned sample met specification as received by medtronic.The visual inspection found no notable conditions.The customer reported bravo fail to attach to patient's esophagus.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found the device to function normally and within specifications.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: 9375397
• Report Number: 9710107-2019-00581
• Device Sequence Number: 13989946
• Product Code: NEZ
• UDI-Device Identifier: 07290101364351
• UDI-Public: 07290101364351
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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 Expiration Date: 02/24/2020
• Device Model Number: FGS-0497
• Device Catalogue Number: FGS-0497
• Device Lot Number: 44862X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 01/19/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1