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

Model Number	FGS-0517
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	07/15/2021
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 was admitted into emergency with capsule retention and was experiencing symptoms of nausea and abdominal pain.The retention was in the small bowel.The small bowel obstruction was possibly complicated by perforation.The patient had a ct scan last month which was normal but showed bilateral inguinal hernias containing bowel.However it did not look as if the capsule was in the groin.The retention was due to patient pathology not equipment or capsule failure.The patient was still in hospital at the time of report.

• Brand Name: PILLCAM
• Common Device Name: COLON CAPSULE IMAGING SYSTEM
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• MDR Report Key: 12315405
• Report Number: 9710107-2021-00372
• Device Sequence Number: 11554719
• Product Code: PGD
• UDI-Device Identifier: 07290101364788
• UDI-Public: 07290101364788
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153466
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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 Model Number: FGS-0517
• Device Catalogue Number: FGS-0517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/12/2021
• 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: Hospitalization; Required Intervention