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

Model Number	FGS-0109
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); Cancer (3262)
Date of Event	08/24/2018
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 patency capsule was still in the ascending colon of the patient as confirmed by the computed tomography and three x-ray's.The patient was then admitted for gastrointestinal bleeding and has a history of colon cancer.The medical advisor explained to the customer that the patency capsule will dissolve and will be expulsed naturally, and that it will be defined as a retained capsule after fifteen days.The patient had a history of prior gastrointestinal bleeding, melena, and colon cancer.The patient is still hospitalized, additional diagnosis pneumonitis and will continue to be monitored and the physician will decide the best action.The x-ray showed some colonic diverticular present and the capsule was seen.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 7887381
• Report Number: 9710107-2018-00951
• Device Sequence Number: 1758256
• Product Code: NSI
• UDI-Device Identifier: 07290101360629
• UDI-Public: 07290101360629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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: 03/12/2019
• Device Model Number: FGS-0109
• Device Catalogue Number: FGS-0109
• Device Lot Number: 39952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/18/2018
• 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: 89 YR
• Patient Weight: 67