BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE82 DELIVERY SYSTEM

    MDR report key: 10726213 · Received October 23, 2020

    Report

    Report Number
    1216677-2020-00245
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 23, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN 1989. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE 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 TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED FOR A LEAKING REGULATOR IN APRIL OF 2001. AN O-RING AND A NEW FILTER ADDRESSED THE ISSUE. 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 95030, THIS UNIT WAS AT CSI ON 10/07/2020. 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 UNITS' 3-WAY VALVE HAD FAILED. ROOT CAUSE: THE 3-WAY VALVE (P/N 21365) WAS NOTED TO HAVE A BAD PLUNGER. THIS WILL IMPACT ITS FUNCTION AND CONSISTENT WITH THE PROBLEM DESCRIPTION IN THAT THE VALVE CAN GET STUCK IN THE OPEN OR CLOSE POSITION. GIVEN THE AGE OF THE DEVICE THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO WEAR AND TEAR AS THE 'PLUNGER' HAS BEEN OBSERVED TO BREAK DOWN AFTER YEARS OF SERVICE. *CORRECTION AND/OR CORRECTIVE ACTION : 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. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    E-COMPLAINT-(B)(4). CUSTOMER STATED "WHEN YOU DEPRESS THE FOOT PEDAL AND RELEASE, THE PROBE REMAINS FROZEN" REFERENCE REPAIR ORDER #(B)(4). 1216677-2020-00245 CE82 DELIVERY SYSTEM 2000 E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER STATED "WHEN YOU DEPRESS THE FOOT PEDAL AND RELEASE, THE PROBE REMAINS FROZEN". REFERENCE REPAIR ORDER #: (B)(4). CE82 DELIVERY SYSTEM 2000 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196139 CE82 DELIVERY SYSTEM CE82 DELIVERY SYSTEM HQA COOPERSURGICAL, INC. 2000 118908

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other