BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 18185671 · Received November 21, 2023

    Report

    Report Number
    1216677-2023-00156
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    November 2, 2023
    Report Date
    October 31, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 6/17/2021 UNDER WO#'S 297987 & 305110 AND SHIPPED ON 9/10/2021. MANUFACTURING RECORD REVIEW: DHR'S 297987 & 305110 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 CONDITION. SEVERAL WERE NOT CONFIRMED, WHILE OTHERS PERTAINED TO A PREVIOUS RECALL ON THE LACK OF ISOLATION ON A CIRCUIT/COMPONENT. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, THIS UNIT WAS SERVICED UNDER LOG 101311 ON 11/16/2023. 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 TESTED TO SPECIFICATIONS, FOUND TO FUNCTION 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

    NO CHANGE TO THE FINAL INVESTIGATION FINDINGS. UPDATING THE UDI NUMBER. CORRECTION TO EMAIL CONTACT.

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEEP WOULD NOT COAGULATE AND DRAGS WHEN CUTTING. NO ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2023-00156, LP-20-120, LEEP 2023-11-0000316.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722669 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 00888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown