BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM CRVD MICRO W/TC

    MDR report key: 10560927 · Received September 21, 2020

    Report

    Report Number
    1216677-2020-00215
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    July 14, 2020
    Report Date
    February 8, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    UDI-DI
    00888937004243
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 6/30/2014 UNDER WO (B)(4) AND SHIPPED ON 7/31/2018. MANUFACTURING RECORD REVIEW: DHR 162072 WAS REVIEWED AND NO NON-CONFORMITIES WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS RETURNED IN JULY 2019 FOR A DAMAGED DELIVERY LINE AND AGAIN IN OCTOBER 2019 FOR NO SEATING. 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 NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT HAD NO SEATING AND LOW FLOW. ROOT CAUSE: THE LOW FLOW WAS ADDRESSED BY REPLACING THE FILTER (P/N 20446). IT ALSO ADDRESSED THE NO SEATING CONDITION. A CLOGGED FILTER IS AN INDICATION THE UNIT WAS LIKELY INADVERTENTLY LAYING IN THE LIQUID IN AN AUTOCLAVE. THIS CAN OCCUR IF THE END WITH THE FILTER (THE CONNECTOR) SLIPS OFF THE TRAY AND INTO THE FLUID. INTAKE OF MOISTURE WILL IMPACT PROPER FUNCTION OF THIS DEVICE. INCLUDING THE FILTER. COMPOUNDED BY THE FACT THAT THIS DEVICE IS A MICRO PROBE UTILIZING A VERY SMALL TUBE TO CONVEY THE GAS THE ROOT CAUSE IS BEING ATTRIBUTED TO END USER ERROR. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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: "HAND PIECE GETS COLD. ORDER: THE HAND PIECE HANDLE WAS FREEZING TO THE SURGEONS GLOVES". 147 1.0MM CRVD MICRO WTC E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC, IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    HAND PIECE GETS COLD. ORDER: 94625. THE HAND PIECE HANDLE WAS FREEZING TO THE SURGEONS GLOVES. ALSO THE HAND PIECE TIP WAS COLD TO TOUCH. REF E-COMPLAINT-(B)(4). 1 0MM CRVD MICRO W-TC 147 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029193 1.0MM CRVD MICRO W/TC 1.0MM CRVD MICRO W/TC HQA COOPERSURGICAL, INC. 147 N/A 00888937004243

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other