BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYO FRZ NO GAS

    MDR report key: 15779477 · Received November 11, 2022

    Report

    Report Number
    1216677-2022-00288
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    March 22, 2022
    Report Date
    January 30, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP FOR CORRECTION TO SECTION E1 COOPER SURGICAL , INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: AS PER SERVICE AND REPAIR, THE COMPLAINT UNIT IS FROM 2005. 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: 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 99315 THIS UNIT WAS AT CSI ON 19-OCT-2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. THE UNIT HAS A SPECIAL UK CONNECTOR INSTALLED. 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 INLET TUBE SCREWS BEING LOOSE AND 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 INLET TUBE SCREWS WERE TIGHTENED AND THE VALVE BODY O-RINGS WERE REPLACED. THE UNIT WAS TESTED AND FOUND ACCEPTABLE. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? YES.

    Additional Manufacturer Narrative · 0

    COOPER SURGICAL , INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    LEAKING. FS LOG # 99315 1216677-2022-00288 LL100 CRYO FRZ NO GAS 900019 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    LEAKING. LL100 CRYO FRZ NO GAS 9000019 (B)(4).

    Description of Event or Problem · 0

    LEAKING. FS LOG # 99315. 1216677-2022-00288 LL100 CRYO FRZ NO GAS 900019 E-COMPLAINT-2022-10-0000411.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2875624 LL100 CRYO FRZ NO GAS LL100 CRYO FRZ NO GAS GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other