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	03/25/2019
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, they had a retained capsule for two weeks.An x-ray was performed and verified that the capsule was in the rectum.The patient experienced no pain and in good condition.
Additional Manufacturer Narrative
Additional information: (model#, catalog#, expiration date, udi).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a retained capsule for two weeks.An x-ray was performed and verified that the capsule was in the rectum.It was noted that the patient experienced no pain and in good condition.The patient has not yet excreted the capsule.The patient current status was feeling well with no bloody stools.The physician performed a colonoscopy which would have been 4 weeks from the procedure and confirmed the capsule have passed.An x-ray abdomen done after the colonoscopy also revealed no capsule anywhere.The patient must have passed it and the caretakers failed to see it in the stool.

• 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: 8547600
• Report Number: 9710107-2019-00182
• Device Sequence Number: 1744118
• Product Code: NEZ
• UDI-Device Identifier: 07290101364399
• UDI-Public: 7290101364399
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Followup
• Report Date (Section B): 05/07/2019

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: 08/06/2019
• Device Model Number: FGS-0497
• Device Catalogue Number: FGS-0497
• Device Lot Number: 42071X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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: 9 YR
• Patient Weight: 23