BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROPOWER OSCILLATOR SAW, PERMANENT LEVER

    MDR report key: 844715 · Received March 1, 2007

    Report

    Report Number
    1017294-2007-00159
    Event Type
    Other
    Date Received
    March 1, 2007
    Date of Event
    February 2, 2007
    Report Date
    February 2, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE SAW WAS REC'D FOR INVESTIGATION AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED. A VISUAL EXAMINATION FOUND A DARK SUBSTANCE AROUND THE EXTERNAL OSCILLATOR SAW RIM/EDGE. FURTHER INVESTIGATION OF THE INTERNAL COMPONENTS FOUND NO ABNORMALITIES OR ABNORMAL DEPOSITS. SOME INTERNAL COMPONENTS OF THIS HANDPIECE ARE LUBRICATED WITH CHEVRON GREASE. IF THIS LUBRICANT DID LEAK FROM THE HANDPIECE, IT IS NON TOXIC. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS OSCILLATING SAW IN FOOT SURGERY, THE DEVICE WAS SPITTING BLACK MATERIAL INTO THE WOUND. THE SURGICAL SITE WAS IRRIGATED WITH ANTIBIOTIC IRRIGATION. THERE WAS NO REPORT OF INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPOWER OSCILLATOR SAW, PERMANENT LEVER OSCILLATING SAW HWE CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention SAW BLADE, CATALOG AND SERIAL NUMBER UNKNOWN