BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 2863645 · Received December 10, 2012

    Report

    Report Number
    1045254-2012-00705
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 9, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4): (1) XOM ENT ENDO UNKNOWN P/N (BLADE), LOT/SERIAL NOT PROVIDED, DATE OF MANUFACTURE UNKNOWN, (2) (B)(4) (IPC CONSOLE), LOT/SERIAL NOT PROVIDED, DATE OF MANUFACTURE UNKNOWN (3) (B)(4) (FOOT SWITCH), LOT/SERIAL NOT PROVIDED, DATE OF MANUFACTURE UNKNOWN.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. THE DEVICE WAS REQUESTED TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION BUT WAS NEVER RETURNED FOR REASONS UNKNOWN. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. THE FOLLOWING CODES WERE NOT AVAILABLE IN MEDTRONIC'S (B)(4) SYSTEM: METHOD: ACTUAL DEVICE NOT EVALUATED (B)(4), RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (B)(4), CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ADENOIDECTOMY, THE CORNER OF THE PATIENTS MOUTH WAS SHAVED OFF WHILE USING A 4.0 RADENOID BLADE IN A MICRODEBRIDER HANDPIECE. THE FACILITY'S INVESTIGATION INTO THE EVENT CONCLUDED THAT THE DEVICES WORKED FINE AND IT WAS SURGEON ERROR. THERE WAS NO DELAY IN SURGERY AND THE PATIENT IS REPORTED AS DOING "FINE" WITH NO PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL XOMED MFG JACKSONVILLE 1898200T NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 00006 YR Required Intervention