BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONIC FTRD SET

    MDR report key: 20693038 · Received November 15, 2024

    Report

    Report Number
    3006696607-2024-00016
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    November 11, 2022
    Report Date
    November 15, 2024
    Manufacturer
    OVESCO ENDOSCOPY AG
    Product Code
    PKL
    UDI-DI
    04260206311010
    PMA / PMN Number
    K170867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LT WAS REPORTED THAT A COLONIC FTRD SET WAS USED FOR AN ENDOSCOPIC FULL THICKNESS RESECTION TO REMOVE AN APPENDICEAL POLYP AT THE APPENDIX ORIFICE. IT WAS ASSUMED THAT THE CLIP OF THE COLONIC FTRD SET IN QUESTION HAD BEEN SUCCESSFULLY APPLIED WITHOUT VISUALLY VERIFYING BEFORE RESECTION. A PERFORATION RESULTED. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT AVAILABLE FOR TECHNICAL ANALYSIS BY US. THE REVIEW OF THE LOT-BASED PRODUCTION RELATED QUALITY RECORDS SHOWED NO ANOMALITIES THAT WOULD RAISE SUSPICION OF TECHNICAL MALFUNCTION OF THE DEVICE. THE RISK OF CAUSING A PERFORATION IS INDICATED IN THE INSTRUCTION OF USE. MOREOVER, IT IS ADDRESSED IN THE USER TRAININGS TO VERIFY SUCCESSFUL CLIP APPLICATION BEFORE RESECTION OF THE TARGET TISSUE. THIS REPORT IS PART OF THE SUBSEQUENT NOTIFICATION, AS COMMUNICATED BY OVESCO ON 24.10.2024 AND REFERS TO: FOLLOW UP QUESTIONS FTRD SYSTEM PERFORATION-CLIP DETACHED FAILURE_ 10-03-2024 ANNEX 1.

    Description of Event or Problem · 0

    LT WAS REPORTED THAT COLONIC FTRD WAS USED FOR POLYP REMOVAL IN THE APPENDIX ORIFICE. SUCCESSFUL CLIP DEPLOYMENT WAS NOT OPTICALLY VERIFIED BY THE USER PRIOR TO TISSUE RESECTION. AS A RESULT, A PERFORATION OCCURRED. THE PATIENT NEEDED LAPAROSCOPIC SURGERY FOR PERFORATION CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186705 COLONIC FTRD SET COLONIC FTRD SYSTEM SET PKL OVESCO ENDOSCOPY AG 14 838712 04260206311010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization