BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 11843010 · Received May 18, 2021

    Report

    Report Number
    1216677-2021-00107
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 8, 2021
    Report Date
    January 23, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010077
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVIEW DHR INSPECT RETURNED SAMPLES DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10/30/2013 UNDER WO #(B)(4) AND SHIPPED ON 11/19/2013. 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 TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED AT CSI ON 12/23/14 AND ON 5/6/2019 FOR BROKEN INSULATOR TUBES. 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. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT WAS STUCK IN FREEZE MODE AT TIMES. ROOT CAUSE: A DEFINITIVE ROOT CAUSE IS NOT AVAILABLE. HOWEVER, THIS UNIT HAS A HISTORY OF BEING DAMAGED AND IN SERVICE FOR SEVERAL YEARS. BASED ON THE ADJUSTMENT MADE TO THE TRIGGER THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO WEAR AND TEAR AND HANDLING. CORRECTIVE ACTIONS THE UNIT'S TRIGGER WAS ADJUSTED, 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

    CUSTOMER STATED: "FREEZE BUTTON SOMETIMES STUCK" 1216677-2021-00107-1 900001 LL100 CRYOSURGICAL (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Description of Event or Problem · 1

    CUSTOMER STATED "FREEZE BUTTON SOMETIMES STUCK". REPAIR TECH STATED "CONFIRMED - ADJUSTED TRIGGER". RO (B)(4). EMAILED REPAIR TECH AND CONFIRMED THE FREEZE WAS UNABLE TO BE TURNED OFF. LL100 CRYOSURGICAL 900001. E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742398 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other