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

Model Number	FGS-0391
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the capsule got impacted to an occlusion and it was still in the patient's digestive tract.The patient was prepped for the procedure, but was not under anesthesia, and a medical intervention was needed as the physician will collect the capsule that was stuck in the patient.It was confirmed with the physician that the patient was going well at this time.
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 patient underwent a pillcam procedure without anesthesia.During the procedure, the capsule impacted an existing occlusion in the patient's digestive tract.No medical intervention was performed to remove the capsule.It is unknown whether the patient has expelled the capsule.It was reported that the patient is doing well at this time.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the capsule got impacted to an occlusion and it was still in the patient's digestive tract.The patient was prepped for the procedure, but was not under anesthesia, and a medical intervention was needed as the physician will collect the capsule that was stuck in the patient.It was confirmed with the physician that the capsule was not removed and the patient was going well at this time.

• 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: 9273472
• Report Number: 9710107-2019-00528
• Device Sequence Number: 13844175
• Product Code: NEZ
• UDI-Device Identifier: 07290101364085
• UDI-Public: 07290101364085
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2020

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: 07/03/2020
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Device Lot Number: 44226U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 01/31/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 11/17/2019; 02/06/2020
• 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