BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 15387283 · Received September 8, 2022

    Report

    Report Number
    1216677-2022-00260
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 26, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS : (B)(4). DISTRIBUTION HISTORY: AS PER SERVICE AND REPAIR, THE COMPLAINT UNIT IS FROM 2001. BASED ON THIS DATE, IT WAS MANUFACTURED AND DISTRIBUTED BY WALLACH SURGICAL DEVICES. THEREFORE A SHIP DATE IS NOT AVAILABLE. 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. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: 88410-NOT FREEZING OR THAWING. CUSTOMER ATTEMPTED TO REPAIR. HIGH PRESSURE LINE DISCONNECTED. 13-MAR-2018. 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 99055 THIS UNIT WAS AT CSI ON 31-AUG-2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. 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 A BROKEN INLET FREEZE LINE AND FREEZE TRIGGER. 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 INLET TUBE ASSEMBLY WAS REPLACED AND THE VALVE BODY WAS REBUILT. THE UNIT WAS TESTED AND FOUND ACCEPTABLE. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. *PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    NOT FREEZING NOR THAWING. FS LOG# (B)(4). 1216677-2022-00260 , LL100 CRYOSURGICAL, 900001, E-COMPLAINT(B)(4).

    Description of Event or Problem · 0

    NOT FREEZING NOR THAWING. FS LOG# (B)(4). LL100 CRYOSURGICAL 900001 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236052 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other