BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 4101271 · Received September 19, 2014

    Report

    Report Number
    0001811755-2014-03297
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT DUPLICATED AND NO FAILURES WERE CONFIRMED AS THE PRODUCT FOR THIS INVESTIGATION WAS NOT AVAILABLE FOR EVALUATION. DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE TPS HANDPIECE CORD CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED, SIGNALING A CONDITION OCCURRED IN WHICH THE HANDPIECE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE TPS HANDPIECE CORD CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED, SIGNALING A CONDITION OCCURRED IN WHICH THE HANDPIECE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582315 TPS HANDPIECE CORD UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO 12153

    Patients

    Seq Age Sex Outcome Treatment
    1