BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 15084747 · Received July 22, 2022

    Report

    Report Number
    1216677-2022-00211
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 22, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 06/05/2017 UNDER WORK ORDER (B)(4) AND SOLD ON 06/23/2017. MANUFACTURING RECORD REVIEW: DHR-223019 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 98645 THIS UNIT WAS AT CSI ON 06/16/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE TRIGGER LEVERS WERE BENT. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO NOT FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE HIGH PRESSURE LINE AND ORINGS LEAKING. THIS IS ATTRIBUTED TO NORMAL WEAR AND TEAR ON THE UNIT. CORRECTION AND/OR CORRECTIVE ACTION. THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE HIGH PRESSURE FITTING TO THE VALVE WAS TIGHTENED, THE ORINGS WERE REPLACED AND THE TRIGGER LEVERS WERE ADJUSTED. THE UNIT WAS TESTED AND FOUND ACCEPTABLE. *PREVENTATIVE ACTION ACTIVITY. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    LEAKING. CONFIRMED COMPLAINT: LEAKING HIGH PRESSURE LINE TO VALVE BODY. LEAKING VALVE BODY O RINGS. BENT TRIGGER LEVERS. REPAIR LOG (B)(4). LL100 CRYOSURGICAL 900001 E-COMPLAINT- (B)(4).

    Description of Event or Problem · 0

    LEAKING. CONFIRMED COMPLAINT: LEAKING HIGH PRESSURE LINE TO VALVE BODY. LEAKING VALVE BODY O RINGS. BENT TRIGGER LEVERS. REPAIR LOG 98645. 1216677-2022-00211 LL100 CRYOSURGICAL 900001 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607826 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other