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

Model Number	FGS-0662
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	05/06/2019
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 in the colon beyond the expected 14 days.Two separate x-rays performed on a different day to confirm the issue.Performed to determine capsule retention and to determine if capsule was still in the colon or had been excreted.The capsule was removed endoscopically from terminal ileum after dilation of ileocolonic anastomosis.The patient was prepped for the procedure and was not under anesthesia.A repeat procedure was not needed.

• 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: 8699431
• Report Number: 9710107-2019-00253
• Device Sequence Number: 1748167
• Product Code: NEZ
• UDI-Device Identifier: 07290110360559
• UDI-Public: 07290110360559
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: 07/05/2019
• Device Model Number: FGS-0662
• Device Catalogue Number: FGS-0662
• Device Lot Number: 41594U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: 33 YR
• Patient Weight: 70