BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE NO-BUTTON SHAVER HANDPIECE

    MDR report key: 3072917 · Received April 23, 2013

    Report

    Report Number
    1017294-2013-00015
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 2, 2013
    Manufacturer
    CONMED LINVATEC
    Product Code
    GEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE D9820 SHAVER HANDPIECE WAS RECEIVED AND EVALUATED BY THE INTERNATIONAL AFFILIATE SERVICE CENTER IN (B)(6). AN EVALUATION FOUND THE UNIT WAS RECEIVED INOPERABLE DUE TO A SEIZED MOTOR. A VISUAL INSPECTION FOUND NO UNUSUAL WEAR PATTERNS ON THE MOTOR OR INTERNAL COMPONENTS THAT WOULD INDICATE THE HANDPIECE WAS OVERHEATED DURING USE. DUE TO THE MOTOR FAILURE, FURTHER TESTING TO DUPLICATE THE REPORTED PROBLEM OF "OVERHEATING" COULD NOT BE PERFORMED. THE REPORTED PROBLEM THEREFORE COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY INDICATED THAT THE HANDPIECE WAS MANUFACTURED ON APRIL 15, 2002 WITH THE LAST SERVICE/REPAIR DATE OF (B)(4) 2012. DURING THIS SERVICE, THE EVALUATION FINDINGS INDICATED THAT THE CABLE WAS REPLACED DUE TO DAMAGE AND ROUTINE MAINTENANCE WAS PERFORMED, WHICH INCLUDED A NEW COLLET O-RING AND REPLACEMENT COMPRESSION SPRING. THE UNIT WAS TESTED PER MANUFACTURER'S TEST PROCEDURE AND PASSED. THE INVOLVED BUR WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED FOR EVALUATION. TO PREVENT THE HANDPIECE FROM OVERHEATING AND TO REDUCE THE RISK OF PATIENT'S INJURY, THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS TO THE USER: CONTINUALLY CHECK ALL HANDPIECES FOR OVERHEATING. IF OVERHEATING IS SENSED, IMMEDIATELY DISCONTINUE USE. OVERHEATING OF THE BLADE OR BUR MAY CAUSE DAMAGE TO THE BLADE OR BUR AND MAY CAUSE THERMAL NECROSIS. RUNNING THE SHAVER BLADE OR BUR WITHOUT FLUID FLOW (DRY) MAY CAUSE DAMAGE TO THE HANDPIECE. WHEN OPERATING BURS AT HIGHER THAN 6000RPM, YOU MUST ENSURE FLUID IS FLOWING THROUGH THE HANDPIECE BEFORE ACTIVATING THE HANDPIECE. FAILURE TO DO SO MAY CAUSE THE BUR HUBS TO MELT DUE TO EXCESSIVE HEAT. DISPOSABLE SHAVER BLADES AND BURS ARE SUPPLIED STERILE AND ARE FOR SINGLE-USE ONLY. DO NOT RE-STERILIZE OR REUSE. THE ABILITY TO EFFECTIVELY CLEAN AND RE-STERILIZE A SINGLE USE DEVICE HAS NOT BEEN ESTABLISHED AND SUBSEQUENT RE-USE MAY ADVERSELY AFFECT THE PERFORMANCE, SAFETY AND/OR STERILITY OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS D9820 ADVANTAGE NO BUTTON SHAVER HANDPIECE WITH A H9111 (4.5 STERLING SPHERICAL BUR) IN A HIP ARTHROSCOPY, THE PATIENT SUSTAINED A SECOND DEGREE BURN AT THE SURGICAL SITE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON COMPLAINED THAT THE BUR WAS SLOWING DOWN EXCESSIVELY WHEN IT MET RESISTANCE AGAINST THE BONE WHILE BURRING. THE SURGEON NOTICED THAT THE HANDPIECE WAS BECOMING VERY HOT TO THE POINT, WHERE IT WAS UNUSABLE. IT WAS ALSO NOTED THAT THE HANDPIECE CONSOLE INTERMITTENTLY DISPLAYED THE "TORQUE LIMITED" SIGN ON THE SCREEN. THE HANDPIECE AND BUR WERE CHANGED AND THE CASE CONTINUED. AT THE END OF THE CASE, WHEN THE SURGICAL DRAPES WERE REMOVED, A BURN WAS NOTED AT THE SURGICAL ENTRY SITE. THE SURGEON EXCISED THE BURNT TISSUE AND THE WOUND WAS SUCCESSFULLY CLOSED. THE PATIENT WAS DISCHARGED AS PER NORMAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174356 ADVANTAGE NO-BUTTON SHAVER HANDPIECE MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY CONMED LINVATEC

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other ITEM #H9111 4.5MM STERLING SPHERICAL BUR, LOT # UN