BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 RECIP SAW

    MDR report key: 4881644 · Received July 1, 2015

    Report

    Report Number
    0001811755-2015-02374
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A STICKY SAFETY SWITCH WAS CONFIRMED. THE SAFETY BAR WAS DIFFICULT TO MOVE DUE TO EXCESSIVE CORROSION ON THE SAFETY BAR ASSEMBLY. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE DEVICE SAFETY SWITCH WAS STICKING, CREATING THE POTENTIAL FOR UNINTENDED ACTIVATION IF THE DEVICE IS STUCK IN A POSITION OTHER THAN "SAFE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE DEVICE SAFETY SWITCH WAS STICKING, CREATING THE POTENTIAL FOR UNINTENDED ACTIVATION IF THE DEVICE IS STUCK IN A POSITION OTHER THAN "SAFE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427051 SYSTEM 7 RECIP SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1