BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 10547431 · Received September 17, 2020

    Report

    Report Number
    1216677-2020-00209
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 11, 2020
    Report Date
    January 20, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010077
    PMA / PMN Number
    K803311
    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

    INVESTIGATION. INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN (B)(6) 1995. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE 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 TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. 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. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE UNIT WAS CONFIRMED TO HAVE BEEN EXPOSED TO COLD SOAK SOLUTIONS. SUCH SOLUTIONS ARE NOT RECOMMENDED FOR CLEANING THE HANDLE AND HOSE SECTION OF THE DEVICE. THE FLUIDS CAN ENTER THROUGH THE HOUSING OR THE INLET/OUTLET AND RESIDUE FORMS INTERNALLY PREVENTING PROPER FUNCTION OF THE VALVE(S). THE ROOT CAUSE FOR THIS FAILURE IS BEING ATTRIBUTED TO END USER ERROR. CORRECTIVE ACTIONS. THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    "WILL NOT DEFROST. VERY DIFFICULT TO REMOVE PROBE DUE TO FROZEN PROBE. ADHERENT TO PATIENT VAGINAL CUFF". 1216677-2020-00209-1 90001 LL100 CRYOSURGICAL(B)(4).

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL, INC . IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    WILL NOT DEFROST. VERY DIFFICULT TO REMOVE PROBE DUE TO FROZEN PROBE. ADHERENT TO PATIENT VAGINAL CUFF. ORDER: (B)(4). CONFIRMED COMPLAINT: PULSE ASSEMBLY AND INSULATOR TUBE CONTAMINATED WITH COLD SOAK SOLUTIONS. HOSE KINKING AT GUN AND GAUGE HOUSING. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015996 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other