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

Model Number	FGS-0497
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	02/21/2019
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 customer called to inquire about the dimensions of the capsule, because the customer believed that the capsule was retained by patient.The patient had an x-ray and they observed metal object on the x-ray image.The patient had been asymptomatic and came in for a routine follow-up.The capsule had reached the colon as what seen on the video.It was explained to the customer that it would be extremely rare for capsule retention in the colon and agreed to share a radiograph demonstrated the capsule on the x-ray for further review.

• 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: 8432074
• Report Number: 9710107-2019-00110
• Device Sequence Number: 13898415
• Product Code: NEZ
• UDI-Device Identifier: 07290101364351
• UDI-Public: 7290101364351
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 08/21/2019
• Device Model Number: FGS-0497
• Device Catalogue Number: FGS-0497
• Device Lot Number: 42215X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/19/2019
• 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: Other