BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 11780433 · Received May 5, 2021

    Report

    Report Number
    1216677-2021-00083
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    March 24, 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
    ES
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INSPECT RETURNED SAMPLES REVIEW DHR DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 11/08/2019 UNDER WO #(B)(4) AND SHIPPED ON 12/06/2019. MANUFACTURING RECORD REVIEW: DHR 272976 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE ATTACHED 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED UNDER WARRANTY. HOWEVER, BASED ON LOG 96069, THIS UNIT WAS AT CSI ON 03/30/2021. 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 NOT DEFROSTING. ROOT CAUSE: A ROOT CAUSE IS NOT DEFINITIVELY DETERMINED. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER UNDER WARRANTY. A REVIEW OF THE TORQUE DRIVERS WAS MADE BUT NO ISSUES WERE NOTED. A REQUEST TO SERVICE & REPAIR WAS MADE TO SET ASIDE ANY OTHER CORE VALVES SUSPECTED OF A CONTRIBUTING TO A STUCK VALVE. 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 "LEAK AT PRESSURE GAUGE" 1216677-2021-00083-1 900001 LL100 CRYOSURGICAL (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "LEAK AT PRESSURE GAUGE". REPAIR TECH STATED "NO LEAK AT GAUGE, BUT DEFROST VALVE STUCK OPEN - REPLACED VALVES, SEALS AND O RINGS". (B)(4). LL100 CRYOSURGICAL 900001. E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675534 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other