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

Model Number	FGS-0568
Medical Device Problem Codes	Signal Artifact/Noise (1036); Insufficient Device Problem Information (3190); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Codes	Diarrhea (1811); Burning Sensation (2146); Radiation Exposure, Unintended (3164)
Date of Event	11/21/2018
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 an 8-hour study with gaps.The patient experienced burning sensations during the digestion process and had a diarrhea four days after the procedure.It was noted that the patient had the first bowel movement approximately 3 hours after capsule ingestion.The patient had kub x-ray (kidney, ureter, bladder) to confirm the capsule exit.Other than that, the patient was stable.A copy of the study was provided for review, and technical support confirmed the study time was 4 hours and 55 minutes, and the issue was the sensor belt.The recorder and sensor belt worked correctly during the previous procedure.There was no user harm.
Additional Manufacturer Narrative
Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, a gfh files was provided by the customer for analysis.The customer reported that they had an 8-hour study with gaps.The reported condition was confirmed.The investigation found that there ware gaps in the study.The investigation identified the cause of the reported event to be poor reception.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: 8258997
• Report Number: 9710107-2019-00025
• Device Sequence Number: 11339519
• Product Code: NEZ
• UDI-Device Identifier: 07290101365884
• UDI-Public: 07290101365884
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/01/2019

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-0568
• Device Catalogue Number: FGS-0568
• Device Lot Number: MA0802040951
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/10/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: Required Intervention
• Patient Age: 40 YR