BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 WITH PINNED YOKE

    MDR report key: 11124755 · Received January 6, 2021

    Report

    Report Number
    1216677-2020-00311
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    July 30, 2020
    Report Date
    January 3, 2021
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). *WAS THE COMPLAINT CONFIRMED? YES . DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 5/31/2017 UNDER WO #'S (B)(4) & (B)(4) AND SHIPPED ON 1/2/2019. MANUFACTURING RECORD REVIEW: DHR #'S 225904 & 225906 WERE 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 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT'S TUBING WAS BENT PREVENTING PROPER FUNCTION. ROOT CAUSE: THE ROOT CAUSE FOR THIS COMPLAINT IS BEING ATTRIBUTED TO END USER HANDLING ERROR. AN OBSTRUCTION OF THE FLOW OF GAS IN THE TUBING, DUE TO BEING BENT, WILL AFFECT PROPER FLOW OF GAS WHILE IN FROST OR DEFROST MODES. CORRECTION AND/OR CORRECTIVE ACTION: THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    FREEZE BUTTON STICKS AND DOESN'T SHUT OFF CORRECTLY, ALLOWING CONTINUED GAS FLOW TO CRYO-TIP. ORDER: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL , INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    FREEZE BUTTON STICKS AND DOESN'T SHUT OFF CORRECTLY, ALLOWING CONTINUED GAS FLOW TO CRYO-TIP. (B)(4). LL100 CRYO FRZ NO GAS 900019 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18220 LL100 WITH PINNED YOKE LL100 WITH PINNED YOKE GEH COOPERSURGICAL, INC. 900019-70 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other