BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR 120VAC

    MDR report key: 19499911 · Received June 10, 2024

    Report

    Report Number
    1216677-2024-00025
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 22, 2024
    Report Date
    July 17, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS BEING RETURNED FOR REPAIR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 09-23-2019 UNDER WO #(B)(4) AND SHIPPED ON 10/16/2019. MANUFACTURING RECORD REVIEW: DHR'S (B)(4) WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. NONE OF THE OBSERVED NOTES INDICATE A SIMILAR ISSUE. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. HOWEVER, SEVERAL WERE NOTED TO BE UNCONFIRMED LIKE THIS UNIT. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED VIA RMA #(B)(4) 6/24/2024. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO OUTER PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: THE DEVICE TESTED TO SPECIFICATION AND FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. A ROOT CAUSE IS NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. THE UNIT WAS EVALUATED, UPDATED WITH R9 & R14 RESISTORS, TESTED TO SPECIFICATIONS FREE OF DEFECTS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PERFORMING AN EXCISIONAL PROCEDURE, THE UNIT TURNED OFF AFTER A FEW MINUTES OF CONTACT. DOCTOR HAD TO WAIT 10-15 SECONDS FOR SUCTION TO END BEFORE CUT/COAG WOULD WORK AGAIN. FOUND A LOOSE SCREW UNDER THE MAIN BOARD. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00025 LP-20-120 LEEP 2024-05-0000577.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659473 LEEP PRECISION GENERATOR 120VAC ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown