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 Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the capsule was stuck in the patient¿s stomach and had an occult blood in stool, but there were no pictures were captured.A week later, the patient wanted to know if the capsule has been excreted.The physician ordered an x-ray, which was read by the radiologist as the capsule broken apart in 2 pieces, both appearing in the colon.The patient has never had any other capsule or patency capsule procedure.The patient was completely asymptomatic.

• 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: 8394072
• Report Number: 9710107-2019-00078
• Device Sequence Number: 13541801
• Product Code: NEZ
• UDI-Device Identifier: 07290101364351
• UDI-Public: 7290101364351
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123864
• 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
• 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: 07/04/2019
• Device Model Number: FGS-0497
• Device Catalogue Number: FGS-0497
• Device Lot Number: 41402X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial 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: Other
• Patient Age: 71 YR