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

Model Number FGS-0661

Device Problem Entrapment of Device (1212)

Patient Problems Abdominal Pain (1685); Inflammation (1932); Vomiting (2144); Radiation Exposure, Unintended (3164)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient ingested a capsule, but it was not expelled yet.They performed a kidney, ureter, and bladder (kub) x-ray and it showed that the capsule was in the central pelvis.The colonoscopy noted a benign structuring at ileocecal valve which was dilated with a balloon catheter, but the capsule was not seen.The patient had an abdominal pain, experienced vomiting, and had an elevated white blood cell.The patient was admitted, and a repeat ct scan showed mild bowel dilatation measuring up to 3.1 centimeters and the capsule was seen resulting in obstruction.The capsule was removed via colonoscopy.The patient was given steroids to decrease inflammation and was doing well with no complications.

Manufacturer Narrative

Correction: if information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient ingested a capsule, but it was not expelled yet.They performed a kidney, ureter, and bladder (kub) x-ray and it showed that the capsule was in the central pelvis.The colonoscopy noted a benign stricturing at ileocecal valve which was dilated with a balloon catheter, but the capsule was not seen.The patient had an abdominal pain, experienced vomiting, and had an elevated white blood cells.The patient was admitted and a repeat ct scan showed mild bowel dilatation measuring up to 3.1 centimeters and the capsule was seen resulting in obstruction.The capsule was removed via colonoscopy.The patient was given steroids to decrease inflammation and was doing well with no complications.

• 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: 8375127
• MDR Text Key: 137297490
• Report Number: 9710107-2019-00070
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290110360542
• UDI-Public: 07290110360542
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/06/2019

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: 04/03/2019
• Device Model Number: FGS-0661
• Device Catalogue Number: FGS-0661
• Device Lot Number: 40300U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 03/06/2019
• Date Device Manufactured: 04/03/2018
• 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: 49 YR