BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 9370832 · Received November 25, 2019

    Report

    Report Number
    1216677-2019-00305
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 28, 2019
    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
    KY, US
    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 8/29/17 UNDER WO #(B)(4) AND SHIPPED ON 1/18/18. MANUFACTURING RECORD REVIEW: DHR 225508 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 CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 93215, THIS UNIT WAS AT CSI ON 10/30/19. 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. THE INLET TUBE VALVE BODY SCREWS WERE LOOSE. ONCE TIGHTENED THE UNIT WAS FUNCTIONAL. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. THE FINDING IS CONSIDERED RARE AS IT HAS NOT BEEN OBSERVED BEFORE AND RESTRICTED TO THIS UNIT. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER UNDER WARRANTY. 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: ""TRIGGER WON'T SHUT OFF". 1216677-2019-00305-1 900001 LL100 CRYOSURGICAL (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "TRIGGER WON'T SHUT OFF". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168231 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other