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

Model Number FGS-0391

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, a capsule was retained in the patient.The capsule presence was confirmed via x-ray and colonoscopy and the doctor was unable to remove it and requested for a medical advisor.

• 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: 8228356
• MDR Text Key: 132431532
• Report Number: 9710107-2019-00013
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101364085
• UDI-Public: 7290101364085
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/08/2019

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: FGS-0391
• Device Catalogue Number: FGS-0391
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/08/2019
• 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