BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 10999319 · Received December 13, 2020

    Report

    Report Number
    1216677-2020-00292
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 13, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT 2020-12-0000033 DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 9/4/2019 UNDER WO #269843 AND SHIPPED ON 9/14/2019. MANUFACTURING RECORD REVIEW: DHR 269843 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS AT CSI UNDER LOG 95205 ON 11/3/2020 FOR A PREVIOUS COMPLAINT (2020-11-0000074). THE UNIT WAS FITTED WITH A NEW MAIN BOARD. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED VIA RMA #313863. 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 PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE IS BEING ATTRIBUTED TO END USER ERROR. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER TO CONFIRM THE ALARM MENTIONED IN THE COMPLAINT WAS IN REGARD TO THE PATIENT PAD LOOSE NOTIFICATION. FURTHER, THE CUSTOMER CONFIRMED THEY HAD USED A CONMED 'MACROLYTE' PAD TYPICALLY FOR SMALLER PATIENTS. COOPERSURGICAL OFFERS LP-50-201 (10 PER BOX) PADS (THERMOGARD) MADE FOR ADULT SIZE PATIENTS AND MAXIMIZES SURFACE AREA NEEDED TO FUNCTION PROPERLY. A SMALLER PAD WOULD BE CONSISTENT WITH THE PATIENT PAD ALARM SOUNDING OFF AS HIGH RF ENERGY DENSITY WOULD RESULT. *CORRECTION AND/OR CORRECTIVE ACTION THIS CUSTOMER WAS ALREADY SENT A REPLACEMENT GENERATOR. THE RETURNED UNIT WAS EVALUATED AND TESTED TO SPECIFICATIONS WITH NO FUNCTIONAL ISSUES. THIS UNIT WAS CONVERTED TO A DEMO. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT YESTERDAY IT MALFUNCTIONED DURING A LEEP. WHEN THE DOCTOR STEPPED ON THE FOOT PEDDLE THE ALARM STARTED SOUNDING AND HE COULD NOT GET IT TO WORK. REF : E-COMPLAINT-2020-12-0000033 1216677-2020-00292 LEEP PRECISION GENERATOR LP-20-120 E-COMPLAINT-2020-12-0000033.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE CONDITON REPORTED.

    Description of Event or Problem · 1

    INCIDENT DETAILS SURROUNDING EVENT. YESTERDAY IT MALFUNCTIONED DURING A LEEP. WHEN THE DOCTOR STEPPED ON THE FOOT PEDDLE THE ALARM STARTED SOUNDING AND HE COULD NOT GET IT TO WORK. (B)(4). LEEP PRECISION GENERATOR LP-20-120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462256 LEEP PRECISION GENERATOR LEEP PRECISION HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other