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

Model Number FGS-0501

Device Problem Entrapment of Device (1212)

Patient Problems Inflammation (1932); Vomiting (2144); Discomfort (2330); Injury (2348); Weight Changes (2607); Radiation Exposure, Unintended (3164); No Information (3190)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9881010
• MDR Text Key: 185481369
• Report Number: 9710107-2020-00147
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101364399
• UDI-Public: 7290101364399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/25/2020
• Date Device Manufactured: 12/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 49