BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 9633464 · Received January 27, 2020

    Report

    Report Number
    1216677-2020-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    October 7, 2019
    Report Date
    April 11, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    *INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 2/07/11 UNDER WO #102623 AND SHIPPED ON 2/24/11. 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 3 SIMILAR REPORTED COMPLAINT CONDITIONS. THE UNITS WERE NOTED TO BE DAMAGED OR REQUIRED REPLACEMENT OF INTERNAL COMPONENTS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 93000, THIS UNIT WAS AT CSI ON 10/3/19. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: THE PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS CONFIRMED TO FUNCTION TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED, AND/OR CHANGED DATA: B1, B3, G3, H6.

    Description of Event or Problem · 0

    WHEN USING CRYO MACHINE IT DRIPPED ON THE PRACTITIONER AND PATIENT. ORDER: 93000 REF (B)(4).

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "WHEN USING THE CRYO MACHINE IT DRIPPED ON THE PRACTITIONER AND PATIENT," AND "IT DRIPPED ON [PRACTIONER'S] FOOT BLISTERING IT."

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    WHEN USING CRYO MACHINE IT DRIPPED ON THE PRACTITIONER AND PATIENT. ORDER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98426 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other