BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 15084975 · Received July 22, 2022

    Report

    Report Number
    1216677-2022-00212
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    May 11, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    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

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-REVIEW DHR : X-INSPECT RETURNED SAMPLES . *ANALYSIS AND FINDINGS : (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 03/10/2022 UNDER WO#'S (B)(4) AND SHIPPED ON 03/17/2022. 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. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4) THIS UNIT WAS AT CSI ON 05/13/2022. 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. A ROOT CAUSE IS NOT READILY AVAILABLE FOR THIS COMPLAINT CONDITION AT THE TIME OF THIS COMPLAINT CLOSURE. *CORRECTION AND/OR CORRECTIVE ACTION: THE CUSTOMER WAS SENT A LOANER WHILE THIS UNIT CAN BE FURTHER EVALUATED. THE UNIT'S RF LEAKAGE CURRENT ERROR WAS NOT VERIFIED DURING THE INITIAL EVALUATION BY SERVICE & REPAIR. WHEN TESTED, THE UNIT FUNCTIONED TO SPECIFICATIONS. A PROJECT (#691) HAS BEEN INITIATED FOR A CONFIRMED LEAKAGE ERROR ON ANOTHER UNIT AND MAY HAVE SOME RELEVANCE ON THIS ONE. IN ADDITION, CAPA 801 WAS INITIATED TO FURTHER EVALUATE THIS COMPLAINT DESCRIPTION AROUND RF LEAKAGE. THIS UNIT WAS RETAINED TO BE PART OF THE OVERALL INVESTIGATION UNDER THE PROJECT AND THE CAPA. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. *PREVENTATIVE ACTION ACTIVITY: REFERENCE CAPA 801.

    Description of Event or Problem · 0

    R/F LEAKAGE ERROR LIGHT WHEN USING CAUTERY BALL ELECTRODE. REPAIR LOG (B)(4). HISTORY: SIMILAR REPORTED. FROM S&R: RF LEAKAGE WARNING STOPS THE UNIT FORM BEING USED. IT IS A SAFETY FEATURE THAT WHEN CURRENT LEAKAGE IS DETECTED THIS COULD BE A SAFETY ISSUE, SO IT KILLS THE POWER TO THE UNIT. LEEP PRECISION GENERATOR LP-20-120 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    R/F LEAKAGE ERROR LIGHT WHEN USING CAUTERY BALL ELECTRODE REPAIR LOG (B)(4). HISTORY: SIMILAR REPORTED. FROM S&R: RF LEAKAGE WARNING STOPS THE UNIT FORM BEING USED. IT IS A SAFETY FEATURE THAT WHEN CURRENT LEAKAGE IS DETECTED THIS COULD BE A SAFETY ISSUE, SO IT KILLS THE POWER TO THE UNIT. LEEP PRECISION GENERATOR LP-20-120 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611312 LEEP PRECISION GENERATOR LEEP PRECISION GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R