BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 18398403 · Received December 27, 2023

    Report

    Report Number
    1216677-2023-00162
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    October 18, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 08/24/2018 UNDER WO#'S 246375 & 248326 AND SHIPPED ON 3/14/2022. MANUFACTURING RECORD REVIEW: DHR'S 246375 & 248326 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 NO SIMILAR REPORTED COMPLAINT CONDITION. THERE ARE SIMILAR REFERENCES TO COAG ISSUES BUT NOT IN REFERENCE TO POWER CYCLES. THIS COMPLAINT IS NOT RELEVANT. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 101444, THIS UNIT WAS AT CSI ON 12/15/2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. HOWEVER, ONE OF THE SMALLER INTERNAL TRANSFORMERS WAS LOOSE AND RESECURED. NO IMPACT TO FUNCTION. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: ONE OBSERVATION IS A NOTE INDICATING THE DOCTOR HAD BEEN ATTEMPTING TO COAG THROUGH A LOT OF BLOOD WHICH IS NOT OPTIMAL. TO COAG, THE WORK SITE MUST HAVE MINIMAL AMOUNT OF BLOOD FOR THE DEVICE TO WORK IN THIS MODE. A POTENTIAL ROOT CAUSE FOR THE ISSUE ENCOUNTERED IS END USER ERROR. A ROOT CAUSE IS NOT APPLICABLE IN REGARD TO THE DEVICE. THE UNIT WAS TESTED TO SPECIFICATIONS FREE OF DEFECTS. ONCE DONE WITH THE TESTING, THE UNIT WAS 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

    G2: FOREIGN: CANADA. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE, THAT THE UNIT WOULD NOT COAGULATE. POWER TO THE UNIT HAD TO BE CYCLED SEVERAL TIMES TO GET THE FUNCTION TO WORK. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2023-00162 LP-20-120 LEEP 2023-12-0000657.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308020 LEEP PRECISION GENERATOR ELECTROSURGICAL SYSTEM GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A 00888937014235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown