BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 15084418 · Received July 22, 2022

    Report

    Report Number
    1216677-2022-00210
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    April 27, 2022
    Report Date
    August 29, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS (B)(4). DISTRIBUTION HISTORY: AS PER SERVICE AND REPAIR, THE COMPLAINT UNIT IS FROM 2004. BASED ON THIS DATE, IT WAS MANUFACTURED AND DISTRIBUTED BY WALLACH SURGICAL DEVICES. 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: 53735-FREEZES INSIDE THE HANDLE-THE O'RINGS AND HIGH PRESSURE FITTING WERE LEAKING-UNIT WAS REPAIRED-01/18/2010. 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 VALVE BODY ORINGS ARE LEAKING. THE HOSE IS KINKING. THE INLET EXHAUST TUBE IS BENT AND CRACKED. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE NORMAL WEAR AND TEAR. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS WERE PERFORMED. DUE TO THE HIGH COSTS OF THE REPAIRS, THE CUSTOMER DECIDED TO NOT HAVE THE UNIT REPAIRED. THE UNIT WAS SCRAPPED. THE CRYO TIP THAT CAME IN WITH THE UNIT WAS RETURNED TO THE CUSTOMER. 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

    PRESSURE DOES NOT GET ABOVE 40 ON THE GAUGE AND DOES NOT GET COLD ENOUGH AT THE TIP CONFIRMED COMPLAINT: LEAKING VALVE BODY O RINGS. KINKING HOSE. INLET EXHAUST TUBE BENT AND CRACKED. REPAIR LOG (B)(4). LL100 CRYOSURGICAL 900001. (B)(4).

    Description of Event or Problem · 0

    PRESSURE DOES NOT GET ABOVE 40 ON THE GAUGE AND DOES NOT GET COLD ENOUGH AT THE TIP CONFIRMED COMPLAINT: LEAKING VALVE BODY O RINGS. KINKING HOSE. INLET EXHAUST TUBE BENT AND CRACKED. REPAIR LOG (B)(4). LL100 CRYOSURGICAL 900001 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566077 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other