BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 15130771 · Received July 29, 2022

    Report

    Report Number
    1216677-2022-00218
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    July 13, 2022
    Report Date
    September 13, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    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

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INSPECT RETURNED SAMPLES; *ANALYSIS AND FINDINGS; COMPLAINT (B)(4). DISTRIBUTION HISTORY: AS PER SERVICE AND REPAIR, THE COMPLAINT UNIT IS FROM 1986. BASED ON THIS DATE, IT WAS MANUFACTURED AND DISTRIBUTED BY WALLACH SURGICAL DEVICES. THE ORIGINAL DHR AND SHIP DATE ARE NOT AVAILABLE. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE, RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: 58308-UNIT IS LEAKING-LEAKING VALVES AND ORINGS, OLD STYLE PULSE ASSEMBLY. REPAIRED AND RETESTED. 10/28/2010. 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. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE HOSE IS DISCOLORED AND IS KINKED. 5 CRYO TIPS WERE ALSO RETURNED, ALL 5 UNITS NEED NEW INSULATORS. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE VALVES AND ORINGS LEAKING. THIS IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR ON THE UNIT. CORRECTIVE ACTIONS; DUE TO THE UNIT BEING 36 YEARS OLD AND THE COST TO REPAIR IT, THE CUSTOMER DECIDED TO PURCHASE A NEW UNIT. THE UNIT AND TIPS WERE RETURNED TO THE CUSTOMER WITHOUT BEING REPAIRED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    TIP NOT FREEZING FAST ENOUGH. LOG 98807. LL100 CRYOSURGICAL 900001 (B)(4).

    Description of Event or Problem · 0

    TIP NOT FREEZING FAST ENOUGH. LOG 98807. LL100 CRYOSURGICAL 900001 E-COMPLAINT-2022-07-0000400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426290 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other