BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 2082569 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01473
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MFR FOR EVAL, BUT BASED ON THE INVESTIGATION DETAILS, THE REPORTED CONDITION OF THE DEVICE LEAKING DURING USAGE COULD NOT BE DUPLICATED. THERE WAS EVIDENCE OF A THIRD PARTY ASIC MOTOR CONTROLLER AND OTHER COMPONENTS. SERVICE REPLACED ALL THIRD PARTY AND BROKEN PARTS. THE DEVICE WILL BE REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PROCEDURE WAS COMPLETED, THE HANDPIECE BEGAN LEAKING A BLOOD-LIKE SUBSTANCE IN SPD DURING CLEANING. THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK