BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 23475510 · Received November 5, 2025

    Report

    Report Number
    1216677-2025-00051
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 15, 2025
    Report Date
    December 30, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED: B4, D9, G3, G6, H2, H3, H4, H6, H11. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 01/24/2019 AND SHIPPED ON 02/11/2019. MANUFACTURING RECORD REVIEW: DHR'S WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: THERE IS NO SERVICE RECORD FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. MAJORITY OF COMPLAINTS WERE NOT CONFIRMED WHILE OTHERS WERE DUE TO PREVIOUS ISSUES NOT RELEVANT ON THIS UNIT AS IT HAD BEEN UPDATED IN 2022. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED 10/17/2025. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ANY RELEVANT CUSTOMER OR CLINICAL INFORMATION: THER WAS NO RELEVANT CUSTOMER OR CLINICAL INFORMATION PROVIDED. 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. NOTE: AS THE UNIT WAS FOUND TO BE OPERATING TO SPECIFICATION IT WAS NOT CONFIRMED. COAG MODE INVOLVES HIGHER VOLTAGE LEVELS AND MINIMAL ISOLATION WEAR IS EXPECTED OVER TIME. THIS MAY RESULT IN A SLIGHT INCREASE IN LEAKAGE CURRENT. THIS INCREASE IS VERY SMALL AND REMAINS WELL WITHIN THE SAFE LIMITS. NO INDICATION RF LEAKAGE APPROACHED THE 120MA LIMIT. REGARDLESS OF A SMALL INCREASE OF LEAKAGE DUE TO WEAR, THE DEVICE'S ELECTRICAL LEAKAGE MONITORING SYSTEM CORRECTLY RESPONDED BY CUTTING POWER. OCCURRENCE IS DEEMED LOW IN PROBABILITY. THE UNIT WAS EVALUATED, ADJUSTED, UPDATED WITH COMPONENTS R8, R9, R14, AND C14 TO THE MOST RECENT REVISION OF THE MAIN BOARD, TESTED TO SPECIFICATIONS 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 THE DEVICE HAS A R/F LEAKING ERROR. NO HARM REPORTED. DEVICE TO BE RETURNED FOR SERVICE. NO ADDITIONAL INFORMATION AVAILABLE. LP-20-120 LEEP 2025-10-0000526.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676799 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 00888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown