BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPOWER OSCILLATOR SAW, DETACHABLE LEVER

    MDR report key: 965010 · Received December 14, 2007

    Report

    Report Number
    1017294-2007-00850
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Report Date
    November 16, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE SAW WAS RECEIVED FOR INVESTIGATION. DURING TESTING OF THIS UNIT NO OILY-LIKE RESIDUE LEAKED FROM THE HANDPIECE. A VISUAL EXAMINATION FOUND A GREASE LIKE SUBSTANCE AROUND OSCILLATING HEAD RIM/EDGE. ADDITIONALLY, THIS USER REPORTED ANOTHER EVENT WITH A UNIT ON LOAN TO THE FACILITY. THIS HANDPIECE WAS SENT OUT TO A THIRD PARTY LAB FOR ANALYSIS ALONG WITH A SAMPLE OF CHEVRON SRI-2 LUBRICANT USED IN THE MANUFACTURE OF THIS PRODUCT. THE LAB ANALYSIS INDICATES THAT THE RESIDUE REMOVED FROM THE OSCILLATING SAW IS COMPOSED OF A FATTY ACID BASED OIL OR COMPOUND WHICH PRECLUDES CHEVRON SRI-2 AS THE SOURCE OF THE UNK RESIDUE. THE INSTRUCTION MANUAL FOR THIS HANDPIECE ALONG WITH THE LABELING FOR THIS PRODUCT INFORMS THE USER NOT TO LUBRICATE THIS HANDPIECE. THE CUSTOMER WILL BE CONTACTED WITH ADDITIONAL INFORMATION ON CARE AND MAINTENANCE OF THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS HANDPIECE IN A BUNIONECTOMY PROCEDURE, A BLACK RESIDUE RESEMBLING OIL LEAKED ONTO THE STERILE FIELD. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR