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

Model Number	FGS-0519
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Choking (2464)
Date of Event	11/08/2021
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 patient choked while swallowing the capsule.It became dislodge in the patient's throat.Heimlich maneuver was performed to remove the capsule.The patient's airway was not obstructed when attempting to swallow the capsule and other attempts were made.

• Brand Name: PILLCAM
• Common Device Name: COLON CAPSULE IMAGING SYSTEM
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 12865264
• Report Number: 9710107-2021-00480
• Device Sequence Number: 11133245
• Product Code: PGD
• UDI-Device Identifier: 07290101364801
• UDI-Public: 07290101364801
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 11/12/2021
• Device Model Number: FGS-0519
• Device Catalogue Number: FGS-0519
• Device Lot Number: 51607C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/23/2021
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female