BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY

    MDR report key: 6443687 · Received March 29, 2017

    Report

    Report Number
    1037007-2017-00003
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    March 1, 2017
    Report Date
    April 27, 2017
    Manufacturer
    OSTA
    Product Code
    ERL
    PMA / PMN Number
    PK772297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THE HANDPIECE TEMPERATURE BECAME HOT WHEN OPERATED OUTSIDE THE SPECIFIED DUTY CYCLE. BASED ON OUR TESTING, MOST HSD HANDPIECES WILL SURPASS THE 48 C HEAT THRESHOLD IF RUN CONTINUOUSLY FOR 8-10 MINUTES (FROM AMBIENT STARTING CONDITIONS RANGING FROM 20-22DEGC). THERE WERE NO OBSERVATIONS OF SMOKE OBSERVED DURING ANY PART OF THE EVALUATION PROCESS. PER DFMEA (B)(4), THE DRILL BODY BECOMING HOT IS IDENTIFIED AS A RECOGNIZED POTENTIAL FAILURE MODE WITH A SEVERITY RATING OF (B)(4). THE IDENTIFIED POTENTIAL EFFECT OF THE FAILURE IS POSSIBLE SURGEON DISCOMFORT AND DELAY OF PROCEDURE ( USER ANNOYANCE). THE DEVICE IS OPERABLE AND SAFE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAND PIECES WERE GETTING HOT. THE OKM TERRITORY MANAGER VISITED AND TESTED THE CUSTOMER¿S HAND PIECES AND HIS OWN AND AFTER RUNNING THEM FOR AROUND 2 MINS THE HAND PIECES ALL GOT HOT. THE OKM TERRITORY MANAGER CHANGED THE ATTACHMENTS AND IT MADE NO DIFFERENCE. THE ATTACHMENTS GOT SO HOT YOU COULD NOT COMFORTABLE HOLD THEM, THE HAND PIECE ITSELF ALSO GOT HOT. AFTER RUNNING FOR A WHILE SMOKE COULD BE SEEN COMING FROM THE HOLES ON THE ATTACHMENTS. FINISHED THE PROCEDURE WITH A SIMILAR DEVICE. 3 DEMONSTRATION STOCK AND ONE CUSTOMER-OWNED HANDPIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223888 HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE ERL OSTA MDHP200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention