BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 20480491 · Received October 18, 2024

    Report

    Report Number
    1216677-2024-00059
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 29, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10/10/2019 AND SHIPPED ON 12/10/2019. MANUFACTURING RECORD REVIEW: DHRS 269843 & 269835 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED AUGUST 13, 2024 FOR A FAULTY MAIN BOARD. THE MAIN BOARD WAS REPLACED, TESTED, AND RETURNED TO THE CUSTOMER. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. AS THIS UNIT WAS NOT CONFIRMED TO HAVE A FUNCTIONAL ISSUE THERE IS NO RELEVANCY. PRODUCT RECEIPT: THE PRODUCT WAS RETURNED 10/10/2024. 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 & FUNCTIONAL TEST SPECIFICATIONS. A ROOT CAUSE IS NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. THE UNIT WAS TESTED TO SPECIFICATION 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.

    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

    IT WAS REPORTED THAT WHILE PERFORMING AN UNKNOWN OBGYN PROCEDURE, THE LEEP WOULD NOT CUT. NO PATIENT HARM REPORTED. UNIT TO RETURN FOR REPAIR. NO ADDITIONAL INFORMATION. LP-20-120 LEEP 2024-10-0000210.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243883 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 00888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown