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

Model Number	FGS-0391
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the capsule was blocked into the small bowel of the patient for months.The patient had been under radiotherapy and there are some risks in performing a surgery to remove the capsule.They were also considering if they should leave it in place.There was no medical intervention done and no patient 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 capsule was blocked into the small bowel of the patient for months.The patient had been under radiotherapy and there are some risks in performing a surgery to remove the capsule.They were also considering if they should leave it in place.There was no medical intervention done and no patient injury.The capsule has not been expulsed yet and for the moment it remains in the patient.

• 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: 7777596
• Report Number: 9710107-2018-00899
• Device Sequence Number: 16415214
• Product Code: NEZ
• UDI-Device Identifier: 07290101364085
• UDI-Public: 07290101364085
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Device Lot Number: 36628U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 68