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

Model Number FGS-0110

Device Problem Entrapment of Device (1212)

Patient Problem Perforation (2001)

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 that swallowed a patency capsule and the capsule caused a perforation which resulted in the patient needing emergency surgery for removal.After 36 hours of swallowing the patency capsule, it was still in full form.There was no reported patient outcome.

• Brand Name: PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9313320
• MDR Text Key: 166123050
• Report Number: 9710107-2019-00544
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101360636
• UDI-Public: 07290101360636
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090557
• 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: 11/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2020
• Device Model Number: FGS-0110
• Device Catalogue Number: FGS-0110
• Device Lot Number: 45902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Date Device Manufactured: 05/02/2019
• 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