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

Model Number	FGS-0391
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
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 was hospitalized for digestive bleeding of obscure origin which was in the middle part of the digestive system, small intestine.The patient swallowed the capsule on (b)(6) 2021.The patient had no swallowing disorders and was able to swallow the capsule without difficulty.5 days after the study was carried out, the patient died with the capsule in the body.The study yielded no results.The patient had no delayed gastric emptying issues and no intervention was done to remove the capsule.When viewing the images, the doctor was able to verify that the capsule was more than 8 hours in the esophagus when the normal thing was that it passes in 15 seconds.It stayed 3 hours in the stomach where the capsule was deactivated due to having exhausted the 11 hours of battery.The study was incomplete because the capsule did not reach the blind colon due to the slowing down of the patient's transit times.The product specialist was able to see the video and observed the same thing that the doctor indicated regarding the totally altered transit times.The capsule progressed through the mucosa of the digestive system, propelled by the peristaltic movements of the patient, and did not have in itself a mechanism that makes it move.There was abnormal gastrointestinal motility found on the video but an x-ray was not performed and may not have been relevant.Based on information obtained thus far, it was unclear if the device contributed to the patient's death.According to the doctor, the death occurred due to multiple organ failure.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• MDR Report Key: 12229094
• Report Number: 9710107-2021-00337
• Device Sequence Number: 11110259
• Product Code: NEZ
• UDI-Device Identifier: 07290101364085
• UDI-Public: 07290101364085
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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 Expiration Date: 09/08/2021
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Device Lot Number: 49569U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/27/2021
• 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: Death
• Patient Age: 72 YR