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

Model Number	FGS-0391
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/28/2018
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 doctor identified that the patient had a retained capsule when the data or study was reviewed, so an x-ray and ct scan was performed for confirmation of the capsule not passing to the cecum.The patient is still an inpatient and is on tube feeding.The patient is not experiencing any discomfort or pain from the capsule, but was operated to obtain the retained capsule.A laparotomy was performed, the capsule was removed and a partial resection of the ileum was undertaken.The capsule was located laparoscopically in the terminal ileum where it was caught by multiple benign strictures, caused by nonsteroidal anti-inflammatory drug (nsaid) overuse.The patient had returned home.

• 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: 7996481
• Report Number: 9710107-2018-01009
• Device Sequence Number: 1381233
• Product Code: NEZ
• UDI-Device Identifier: 07290101364085
• UDI-Public: 7290101364085
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 09/01/2018
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Device Lot Number: 34618U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 50