BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE82 DELIVERY SYSTEM

    MDR report key: 10301214 · Received July 21, 2020

    Report

    Report Number
    1216677-2020-00156
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 30, 2020
    Report Date
    September 23, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED 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: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. 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 94550, THIS UNIT WAS AT CSI ON 7/09/2020. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO OUTER PHYSICAL DAMAGE TO THE CASING. A HIGH PRESSURE LINE WAS ALSO NOTED TO BE CRACKED. ALL LINES ARE INTERNAL. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT'S 3-WAY VALVE (P/N 21365) WAS NOT OPERATING. THIS IS CONSISTENT WITH THE COMPLAINT DESCRIPTION. ROOT CAUSE: THE ROOT CAUSE IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR FOR A DEVICE IN SERVICE FOR 21 YEARS. THE 3-WAY VALVE CONTROLS THE DIRECTION/FLOW OF GAS, EXHAUST AND ACTIVATED VIA THE FOOT PEDAL. IT IS LIKELY THE PISTON INSIDE DRIED OUT AFTER YEARS OF SERVICE. WAS THE COMPLAINT CONFIRMED? YES . 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. PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    FOOT PEDAL WOULD NOT RELEASE. ORDER: (B)(4). REF: (B)(4). 1216677-2020-00156 CE82 DELIVERY SYSTEM 2000 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION .

    Description of Event or Problem · 1

    FOOT PEDAL WOULD NOT RELEASE. (B)(4). CE82 DELIVERY SYSTEM 2000 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770043 CE82 DELIVERY SYSTEM CE82 DELIVERY SYSTEM HQA COOPERSURGICAL, INC. 2000 088903R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other