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

Model Number	FGS-0110
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	02/18/2019
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 retained capsule.The kub (kidney, ureter, bladder) x-ray done showed that the previously noted rectangular radiodensity was now apparent at the left aspect of the abdomen/upper pelvis, at the level of the pelvic brim, probably in the descending colon.It was assumed that the patient passed the capsule.The patient reported daily bowel movement with no abdominal pain.The last known patient status was doing well.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8422999
• Report Number: 9710107-2019-00092
• Device Sequence Number: 2242025
• Product Code: NSI
• UDI-Device Identifier: 07290101360636
• UDI-Public: 07290101360636
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/14/2019

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 Expiration Date: 11/26/2019
• Device Model Number: FGS-0110
• Device Catalogue Number: FGS-0110
• Device Lot Number: 43713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/14/2019
• 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: 56 YR
• Patient Weight: 67