BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 17930493 · Received October 13, 2023

    Report

    Report Number
    1216677-2023-00136
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    October 3, 2023
    Report Date
    November 30, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS IS A DUPLICATE COMPLAINT OF A PREVIOUSLY REPORTED EVENT. THE INITIAL REPORT 1216677-2023-00136 WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THE DEVICE WAS REPORTED BY THE CUSTOMER AND THEN REPORTED AGAIN BY OUR REPAIR DEPARTMENT. THE COMPLAINT WAS PREVIOUSLY REPORTED UNDER 1216677-2023-00132. THE FINAL INVESTIGATION RESULTS WILL BE COMPLETED UNDER THIS COMPLAINT NUMBER.

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: CANADA. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS IS A DUPLICATE COMPLAINT OF A PREVIOUSLY REPORTED EVENT. THE INITIAL REPORT 1216677-2023-00136 WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THE DEVICE WAS REPORTED BY THE CUSTOMER AND THEN REPORTED AGAIN BY OUR REPAIR DEPARTMENT. THE COMPLAINT WAS PREVIOUSLY REPORTED UNDER 1216677-2023-00132. THE FINAL INVESTIGATION RESULTS WILL BE COMPLETED UNDER THIS COMPLAINT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEEP GENERATOR IS NOT WORKING CONSISTENTLY. HAD ISSUE WITH COAGULATION MODE. USED 3 HAND PIECES AND 4 BALL CAUTERY TO COMPLETE PROCEDURE. NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. 1216677-2023-00136 LP-20-120 LEEP 2023-10-0000175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552439 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 2021020002 888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown