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

Model Number	FGS-0501
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Inflammation (1932); Vomiting (2144); Discomfort (2330); Injury (2348); Weight Changes (2607); Radiation Exposure, Unintended (3164); No Information (3190)
Date of Event	08/15/2019
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 patient in which the capsule was retained for over 7 months.Patency capsule was performed prior to the procedure.The patient reported vomiting, discomfort, and losing weight but it was unclear whether or not this has been continuous and for how long this has been going on.The capsule retention was verified initially through abdominal x-ray and it showed that it had not reached the cecum.This was also confirmed with a subsequent ct scan.The patient went through several serial abdominal x-rays to assess passage.Once it was apparent that the capsule had not passed after several weeks, it was recommended to have the patient start corticosteroids for active inflammation secondary to crohn's disease in which the patient refused.They suspected that the capsule was stuck proximal to an inflammatory stricture and treatment of this may aid in capsule passage.It was also recommended that the patient start biologic therapy which the patient also refused.The patient was referred to an institution that could perform double balloon enteroscopy but was not able to be seen there.The patient underwent retrograde single balloon enteroscopy which failed in reaching the capsule.The patient was last seen on (b)(6) 2020 in which they had the failed single balloon enteroscopy, since then, the patient missed office follow up.There was no user harm.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• MDR Report Key: 9881010
• Report Number: 9710107-2020-00147
• Device Sequence Number: 3419079
• Product Code: NEZ
• UDI-Device Identifier: 07290101364399
• UDI-Public: 7290101364399
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2020

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: 06/25/2020
• Device Model Number: FGS-0501
• Device Catalogue Number: FGS-0501
• Device Lot Number: 43953S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/25/2020
• 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: 61 YR
• Patient Weight: 49