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

Model Number	FGS-0661
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Abdominal Pain (1685); Inflammation (1932); Vomiting (2144); Radiation Exposure, Unintended (3164)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
Correction: if information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 8375127
• Report Number: 9710107-2019-00070
• Device Sequence Number: 1697484
• Product Code: NEZ
• UDI-Device Identifier: 07290110360542
• UDI-Public: 07290110360542
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR