BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 18002954 · Received October 25, 2023

    Report

    Report Number
    1216677-2023-00138
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 28, 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: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 19-APR-2021 UNDER WORK ORDER (B)(4) AND SOLD ON 30-APR-2021 AS LP-10-120. MANUFACTURING RECORD REVIEW: DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 101131 THIS UNIT WAS AT CSI ON 19-OCT-2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE ZENER DIODE UPDATE SHORTING OUT TO THE BOARD. THIS IS AN ISOLATED INCIDENT WITH AN ISSUE WITH THE KAPTON TAPE. THIS IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR. THE MAIN BOARD WAS REPLACED. THE UNIT WAS TESTED OK AND WAS RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    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 WHILE PERFORMING OB/GYN PROCEDURE, THE LEEP GENERATOR WOULD NOT CUT/CAUTERIZE AND IT MAKES SOME EXTRA BEEPING SOUNDS. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. LP-20-120 LEEP 2023-10-0000466.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838259 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 00888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female