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

Model Number	FGS-0501
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); 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 was aspirated into the patient's lungs.The patient underwent an x-ray to verify the capsule location and underwent a surgery to remove it.The capsule was placed in the duodenum to complete the study.The recorder was removed from the patient and the video was downloaded and then it was placed back to the patient without rechecking-in.Technical support informed the customer that the data could not be possibly obtained since the patient was not checked-in post-surgery.Technical support confirmed with the customer that the patient underwent the additional surgery, but was clinically doing well.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 8208505
• Report Number: 9710107-2019-00001
• Device Sequence Number: 16195983
• Product Code: NEZ
• UDI-Device Identifier: 07290101364399
• UDI-Public: 7290101364399
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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 Model Number: FGS-0501
• Device Catalogue Number: FGS-0501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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