BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OP 80 INPUT HOSE

    MDR report key: 3173329 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01406
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K863447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS DUPLICATED. IT WAS CONFIRMED THE DEVICE WAS NOT PRODUCING ENOUGH AIR PRESSURE. PER VISUAL INSPECTION, THE HOSE WAS FOUND TO BE LEAKING AIR BECAUSE IT HAD SEPARATED FROM ITS DAMAGED FITTING. THE PRESENCE OF A DAMAGED EXHAUST FERRULE COMPONENT IS LIKELY TO CAUSE OR CONTRIBUTE TO THE REPORTED EVENT OF LOW AIR PRESSURE. THE DEVICE WAS NOT REPAIRED BUT RETURNED TO THE CUSTOMER

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN AIR LEAK AT THE BOTTOM OF THE OP 80 INPUT HOSE NEAR THE FOOT PEDAL DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN AIR LEAK AT THE BOTTOM OF THE OP 80 INPUT HOSE NEAR THE FOOT PEDAL DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274508 OP 80 INPUT HOSE MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED GET STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1