BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 15824561 · Received November 18, 2022

    Report

    Report Number
    1216677-2022-00301
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    September 19, 2022
    Report Date
    November 17, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    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 X-REVIEW DHR X-INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS COMPLAINT(B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 13-JAN-2021 UNDER WORK ORDER 297567 AND SOLD ON 14-JUL-2021. MANUFACTURING RECORD REVIEW: DHR-297567 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 99410 THIS UNIT WAS AT CSI ON 04-NOV-2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGED. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE LEAKING VALVE BODY O-RINGS. THIS IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR ON THE UNIT. CORRECTION AND/OR CORRECTIVE ACTION THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE VALVE BODY O-RINGS WERE REPLACED. THE UNIT WAS TESTED PER FORM-PROD 263 AND FOUND ACCEPTABLE. NO FURTHER TRAINING REQUIRED AT THIS TIME. PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    FREEZING GAS CAME FROM BETWEEN THE FRZ -ADN - DEF TRIGGER. FS LOG # 99410. 1216677-2022-00301 LL100 CRYOSURGICAL 900001 (B)(4).

    Description of Event or Problem · 0

    FREEZING GAS CAME FROM BETWEEN THE FRZ -ADN - DEF TRIGGER. FS LOG#: 99410. LL100 CRYOSURGICAL 900001 E-COMPLAINT: (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237668 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other