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

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, patients with known or suspected crohn¿s disease (cd) underwent complete examination for an evaluation of the small bowel.There was one case of stomach retention of the capsule, which occurred despite having a patency check.A follow-up plain abdominal x-ray was performed, and the patency capsule had been reported to be in the large bowel.There was no reported patient outcome.

Manufacturer Narrative

Additional info:(catalog#, model#).If information is provided in the future, a supplemental report will be issued.

Event Description

Capsule had been reported to be in the large bowel.There was no reported patient outcome.

• Brand Name: UNKNOWN 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: 8232133
• MDR Text Key: 132549623
• Report Number: 9710107-2019-00016
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101361404
• UDI-Public: 07290101361404
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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 Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 04/11/2019
• 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
• Patient Age: 66 YR