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

Model Number	FGS-0391
Medical Device Problem Codes	Entrapment of Device (1212); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	08/27/2021
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, they had a short study.The customer called stating that the patient returned from a capsule study and on inspection of the viewer it was still in the small bowel.The patient was told to go for a walk and came back half an hour later.The orange light on the recorder was flashing but there was no view on the recorder.The customer then disconnected the sensor after they had the orange light and nothing on the screen.The recorder was only flashing orange and black image when they checked the live view, after the patient went back to the hospital.Technical support asked the customer to check with the doctor after review to confirm if the capsule had reached the small bowel.The customer called back and stated that the notes from the doctor confirmed that the capsule had not reached the colon.When the doctor was that the end video was still in small bowel the doctor had them have an x-ray due to suspected capsule retainment.However it was confirmed that the capsule was passed naturally by the patient.The recorder and sensor belt worked without issue previously.There was no patient or user harm.

• 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: 12576389
• Report Number: 9710107-2021-00435
• Device Sequence Number: 3488277
• Product Code: NEZ
• UDI-Device Identifier: 07290101364085
• UDI-Public: 07290101364085
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: 01/01/2023
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Device Lot Number: 53854U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/05/2021
• 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: Other