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

Model Number	FGS-0501
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Injury (2348); Radiation Exposure, Unintended (3164)
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 capsule showed up in an x-ray two days after ingestion.They were advised to take an x-ray on day 15th of the procedure.There was no reported patient outcome.

• 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: 8465725
• Report Number: 9710107-2019-00134
• Device Sequence Number: 1628534
• Product Code: NEZ
• UDI-Device Identifier: 07290101364399
• UDI-Public: 7290101364399
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• 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): 03/29/2019

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: 02/23/2020
• Device Model Number: FGS-0501
• Device Catalogue Number: FGS-0501
• Device Lot Number: 42268S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/29/2019
• 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: 37 YR