BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS BI-DIRECTIONAL FOOTSWITCH

    MDR report key: 3052841 · Received April 11, 2013

    Report

    Report Number
    0001811755-2013-00759
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT THE FOOTSWITCH OUTER SHEATHING ON THE CABLE OF THE FOOTSWITCH WAS CUT; THERE WERE NO BARE VISIBLE COPPER WIRES. BASED ON A REVIEW OF THE RISK DOCUMENT POSSIBLE CAUSES ARE DUE TO FLEXING OR WRAPPING OF THE CABLE DURING USE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER MARKETING ASSOCIATE NOTICED THAT A STOCK LAB TPS BI-DIRECTIONAL FOOTSWITCH CORD HAD EXPOSED WIRES. THERE WAS NO PATIENT INVOLVMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER MARKETING ASSOCIATE NOTICED THAT A STOCK LAB TPS BI-DIRECTIONAL FOOTSWITCH CORD HAD EXPOSED WIRES. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155899 TPS BI-DIRECTIONAL FOOTSWITCH DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1