BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURB LEEP PRECISION GEN

    MDR report key: 17050265 · Received June 2, 2023

    Report

    Report Number
    1216677-2023-00089
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 21, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937019926
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 5/20/2016 UNDER WO#'S (B)(4) AND CONVERTED TO DEMO ON WORK ORDER (B)(4) ON 8/4/2016. MANUFACTURING RECORD REVIEW: DHRS 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. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 100398, THIS UNIT WAS AT CSI ON (B)(6) 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: ALTHOUGH NOT CONFIRMED ON THIS UNIT CAPA 801 HAD BEEN ISSUED TO DETERMINE A ROOT CAUSE ON RF LEAKAGE COMPLAINTS. BASED ON THE FINDINGS, THE DESIGN IS INTACT AND NOT FAULTY. THE LEEP SYSTEM IS DESIGNED WITH A SAFETY FEATURE TO CUT POWER IN ANY MODE WHEN RF LEAKAGE IS DETECTED. THIS IS IN PLACE TO PROTECT THE END USER AND PATIENT FROM POTENTIAL SHOCK. IN THE INVESTIGATION, THE FAILURE HAD BEEN REPEATED, BUT UNDER CERTAIN CONDITIONS RELEVANT TO SET UP/ENVIRONMENT. THE UNIT WAS EVALUATED, TESTED AND RETURNED TO THE CUSTOMER. ALL PRODUCT WAS PLACED ON HOLD AND LATER RELEASED PER AN EVALUATION OF THE FINDINGS ON THE CAPA INVESTIGATION. THE INVESTIGATION PORTION OF THE CAPA PROCESS WILL BE CONSIDERED COMPLETE BUT THE IMPLEMENTATION PORTION WILL CONTINUE WITH SOME ACTIONS BASED ON THE INVESTIGATION. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    AS PER DETAILS REPORTED ON (B)(4) FROM FS LOG # 100398. "INTERMITTENT RF LEAKAGE DURING USE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623075 REFURB LEEP PRECISION GEN REFURB LEEP PRECISION GEN HGI COOPERSURGICAL, INC. DMLP-20-120 N/A 00888937019926

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other