BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 21605425 · Received March 14, 2025

    Report

    Report Number
    1216677-2025-00012
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 1, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937014235
    PMA / PMN Number
    K963653
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B4, D9, G3, G6, H2, H3, H4, H6, H11. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 12/16/2016 AND SHIPPED ON 3/7/2017. MANUFACTURING RECORD REVIEW: DHR'S WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: THIS UNIT HAD BEEN RETURNED TWICE UNDER SEPARATE RECALLS FOR REPAIRS UNDER (B)(4) ON 1/27/2020 AND (B)(4) ON 4/22/2022. IN 2020 THE BOARD WAS UPDATED TO INCLUDE A ZENER DIODE AND A CAPACITOR WHILE IN 2022 THE BOARD WAS UPDATED AGAIN WITH RESISTORS ON R9 AND R14. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY HAS SIMILAR REPORTED COMPLAINT CONDITION. THE MAJORITY OF COMPLAINTS WERE NOT CONFIRMED. THE FEW REMAINING COMPLAINTS WERE CONFIRMED FOR UNRELATED REASONS NOT INDICATIVE OF A TREND. THIS UNIT WAS FREE OF DEFECTS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON 3/3/2025. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO 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 AND TESTED TO SPECIFICATIONS FREE OF DEFECTS. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    DEVICE IS BEING RETURNED FOR SERVICE. 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 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE COAG FEATURE ON THE LEEP WAS NOT WORKING. NO PATIENT HARM WAS REPORTED, BUT MEDICATION WAS ADMINISTERED TO STOP THE BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE TO BE RETURNED FOR SERVICE. LP-20-120 LEEP 2025-03-0000054.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228017 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 00888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention