BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI DRIVE MOTOR

    MDR report key: 5233621 · Received November 18, 2015

    Report

    Report Number
    0001811755-2015-04207
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 21, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K141935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED SEIZING, AND REPORTED THAT THE DEVICE HAD CABLE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS DETERMINED TO HAVE A SEVERED ELECTRICAL CABLE, WITH EXPOSED COPPER WIRE. AS THIS OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS DETERMINED TO HAVE A SEVERED ELECTRICAL CABLE, WITH EXPOSED COPPER WIRE. AS THIS OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764069 PI DRIVE MOTOR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1