BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR 120VAC

    MDR report key: 18987836 · Received March 27, 2024

    Report

    Report Number
    1216677-2024-00014
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 14, 2024
    Report Date
    May 21, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    888937014235
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 09/01/2021 UNDER WO#'S (B)(4) AND SHIPPED ON 09/01/2021. MANUFACTURING RECORD REVIEW: DHR'S (B)(4) 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. FINDINGS CAN VARY BETWEEN NOT CONFIRMED TO DAMAGE. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, THE UNIT WAS REVIEWED 3/21/2024. 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 UNIT WAS EVALUATED AND FOUND TO FUNCTION TO SPECIFICATIONS FREE OF DEFECTS. AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS A ROOT CAUSE IS NOT APPLICABLE. COMPLAINT WAS NOT CONFIRMED. THE UNIT WAS EVALUATED, TESTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE GENERATOR FAILED TO ADEQUATELY CAUTERIZE. NO PATIENT INJURY. UNIT TO BE RETURNED FOR REPAIR. NO ADDITIONAL INFORMATION. LP-20-120 LEEP 2024-03-0000766

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131028 LEEP PRECISION GENERATOR 120VAC ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown