BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP PRECISION GENERATOR

    MDR report key: 15258152 · Received August 19, 2022

    Report

    Report Number
    1216677-2022-00229
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    August 4, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K963653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 REVIEW DHR INSPECT RETURNED SAMPLES . A N ALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 05/02/2019 UNDER WO#'S (B)(4). AND SHIPPED 06/26/2019. MANUFACTURING RECORD REVIEW: DHR'S (B)(4) 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: ALTHOUGH ON REPAIR THE COMPLAINT UNIT WAS RETURNED VIA RMA 334745 ON 8/12/2022 UNDER AN UNRELATED RECALL. 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: A DEFINITIVE ROOT CAUSE IS NOT DETERMINABLE. THE UNIT FUNCTIONED FREE OF DEFECTS WITH THE EXCEPTION OF THE COAG RF LEAKAGE BEING SLIGHTLY OUT OF TOLERANCE. AN IMPACTFUL RF LEAKAGE ERROR WOULD BE A DIFFERENT FAILURE MODE WHERE THERE WOULD BE NO OUTPUT IN ANY MODE AND NOT CONSIDERED RELEVANT TO THIS COMPLAINT. IT IS POSSIBLE THE PATIENT PAD WAS LOOSE OR THE NOT FULLY ADHERED REDUCING THE AREA COVERED. IT IS ALSO POSSIBLE THE PATIENT PAD WAS NOT PLACED AS CLOSE AS POSSIBLE TO THE OPERATIONAL SITE. PER THE GUIDANCE IN THE IFU, THE PAD SHOULD BE PLACED ON THE LEG'S THIGH CLOSE TO THE OPERATIONAL SITE. CORRECTIVE ACTIONS THE UNIT WAS RECEIVED AND PROCESSED UNDER THE RECALL RMA FOR AN UNRELATED COAG ISSUE. PRIOR TO THE FULL TESTING OF THE UNIT UNDER WO (B)(4) , THE R77 WAS ADJUSTED TO GET THE RF LEAKAGE WITHIN TOLERANCE. CAPA 801 WAS INITIATED TO INVESTIGATE RF LEAKAGE ERRORS WHICH INCLUDES THE OBSERVATION ON THIS UNIT FOUND TO BE SLIGHTLY OUT OF TOLERANCE. NO FURTHER TRAINING REQUIRED. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    EXTERNAL LEEP USE, LABIA WAS BURNED. LOG (B)(4). LEEP PRECISION GENERATOR LP-20-120 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    EXTERNAL LEEP USE, LABIA WAS BURNED. LOG (B)(4). 1216677-2022-00229-1, L EEP PRECISION GENERATOR LP-20-120 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575571 LEEP PRECISION GENERATOR LEEP PRECISION GENERATOR HGI COOPERSURGICAL, INC. LP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other