BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 22373510 · Received July 1, 2025

    Report

    Report Number
    1216677-2025-00036
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 21, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B4, D9, G3, G6, H2, H3, H4, H6, H7, H11. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 06/9/2017 AND SHIPPED ON 8/21/2017. MANUFACTURING RECORD REVIEW: DHRS 222987 & 224637 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED 8/8/2019 FOR AN UPDATE TO C21 AND IN 2022 UNDER A RECALL TO UPDATE THE MAIN BOARD WITH THE LATEST UPDATES TO COMPONENTS ON THE MAIN BOARD. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. MAJORITY OF COMPLAINTS WERE NOT CONFIRMED. ONE WAS FOUND WITH A SHORTED C21 COMPONENT AND DEEMED AS AN ISOLATED INCIDENT. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED 06/25/2025. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. ONE OF THE RUBBER FEET (BUMPERS) WAS MISSING AND A TRANSFORMER ON THE BACK END OF THE BOARD ON L1 HAD BEEN COMPLETELY SEPARATED AND LOOSE IN THE CHASSIS. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO NOT FUNCTION PROPERLY. ROOT CAUSE: GIVEN THE AGE OF THE DEVICE AND DAMAGE OBSERVED, THE ROOT CAUSE IS ATTRIBUTED TO WEAR AND TEAR. THE TRANSFORMER IS SECURED IN PLACE WITH A TY-WRAP AND THIS UNIT HAS NO PREVIOUS RECORD OF SERVICE CONCERNING THIS COMPLAINT UNIT WHERE THERE WAS POWER BUT NO OUTPUT IN ANY MODE OR NO SMOKE EVACUATION (PURGE) FUNCTION. FOR THE TRANSFORMER TO HAVE BEEN DISCONNECTED (BROKEN LEADS) INDICATES IT WAS IMPACTED OR HANDLED ROUGHLY OVER TIME TO EVENTUALLY WEAR AWAY THE LEADS. THE OBSERVABLE FAILURE NOTED BY THE CUSTOMER IS IN LINE WITH THE TRANSFORMER NO LONGER BEING CONNECTED. IT FEEDS THE RF POWER, 5V AND 15V, THE CIRCUITRY USES. THE UNIT WAS EVALUATED, REPAIRED, 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025, THE LEEP WOULD TURN ON, BUT WOULD NOT PURGE, CUT, OR COAG. CUSTOMER STATED THAT NOTHING SEEMS TO FUNCTION. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. DEVICE TO BE RETURNED FOR REPAIR. LEEP LP-20-120 2025-06-0000530.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418800 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 00888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown