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

Model Number FGS-0109

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient who had the patency capsule 2 weeks ago has still got the patency in the small bowel.It was thought on x-ray that the patency was in the rectum, so they went ahead and had the capsule endoscopy but got held up behind a stricture probably in a loop of small bowel sitting over the rectum.The patency was seen thru the capsule endoscopy, squashed down but still there.It was also reported that the pillcam capsule was also retained.The patient is due for surgery to remove the stricture, patency capsule and pillcam.

• Brand Name: PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 11581632
• MDR Text Key: 242703165
• Report Number: 9710107-2021-00163
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101360629
• UDI-Public: 07290101360629
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K090557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2021

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: 09/01/2021
• Device Model Number: FGS-0109
• Device Catalogue Number: FGS-0109
• Device Lot Number: 50949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/29/2021
• Date Device Manufactured: 09/01/2020
• 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: 31 YR
• Patient Weight: 70