BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE 1896200 STRAIGHTSHOT MAGNUM

    MDR report key: 2032203 · Received March 29, 2011

    Report

    Report Number
    1045254-2011-00020
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HRX
    PMA / PMN Number
    K973499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT, IN AN AS-RECEIVED CONDITION, DID NOT MEET SPECIFICATION. CLARIFICATION TO "PRODUCT CODE": THE 510K REFERENCED SHOWS AS PRODUCT CODE HRX "ARTHROSCOPE" IN THE MAUDE DATABASE. OUR RECORDS INDICATE THE PRODUCT CODE TO BE ERL "DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE". PRODUCT CODE ERL APPEARS TO BE A MORE ACCURATE DESCRIPTION OF THE DEVICE IN QUESTION. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT PROBLEM HAS CAUSED THERMAL DAMAGE IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. THERE WAS NO SURGICAL / MEDICAL INTERVENTION OR PATIENT INJURY AS A RESULT OF THE EVENT. THIS REPORT IS BEING FILED AS A PRODUCT PROBLEM WITHOUT ADVERSE EVENT / INTERVENTION TO PRECLUDE SERIOUS INJURY.

    Description of Event or Problem · 1

    DESCRIPTION OF THE ORIGINAL COMPLAINT: "THE DRILL BECAME EXTREMELY HOT AND BURNED THE SURGICAL DRAPE." NO PATIENT INJURY WAS INDICATED. RELEVANT EVENTS AND INFORMATION OBTAINED FOR THE REPORTED INCIDENT: JUST PRIOR TO THE INCIDENT THE SURGEON WAS PERFORMING SINUS SURGERY, RUNNING THE DEVICE AT 3,000 RPM VARIABLE SPEED. THE USER FACILITY STATED "DURING THE CASE THE HANDPIECE WAS LAID ON THE SURGICAL DRAPES, ON THE PATIENT'S ABDOMEN. THIS HAND PIECE WAS SO HOT THAT IT MELTED THROUGH THE DRAPING. FORTUNATELY THERE WAS NO PATIENT INJURY." SUBSEQUENT TO THE EVENT, THE FACILITY STATED "SURGERY COMPLETED, MOTOR WAS NOT ENGAGED. REMOVED BY SCRUB TECH, THE HANDPIECE WAS TOO HOT FOR HIM TO HOLD." THERE WAS NO ADVERSE PATIENT CONSEQUENCES OR SEQUELA REPORTED. NO DELAY OF SURGERY OR ADDITIONAL FOLLOW-UP CARE REQUIRED AS A RESULT OF THIS EVENT. VISUAL INSPECTION SHOWED THAT THE CABLE IS KINKED IN SEVERAL LOCATIONS AND WHAT APPEARS TO BE, BLUE PLASTIC MELTED INTO THE ETCHING ON THE HANDPIECE HOUSING. THE HANDPIECE WAS FUNCTIONALLY TESTED ON 3 SEPARATE CONSOLES AND IT FAILED TO ROTATE. TURNING THE SHAFT USING A DISPOSABLE INNER BLADE SHOWED THE SHAFT WAS LOCKED UP. THE MOTOR CABLE ASSEMBLY WAS REMOVED FROM THE MOTOR HOUSING AND FOUND TO BE SEIZED. FOREIGN MATERIAL DEBRIS WAS ON THE MOTOR CASE AND ON THE MOTOR HOUSING. THE COLLET ADAPTER WAS ALSO SEIZED WITH CORROSION AND HEAVY FOREIGN MATERIAL CONTAMINATION. THE COLLET FROM THE FRONT OF THE HANDPIECE FUNCTIONS NORMALLY AND NO DAMAGE OR DEFECT IS PRESENT. THE ANALYSIS CONCLUDES THAT A DEVICE IN THE FIELD FOR MORE THAN 8 YEARS WITHOUT SERVICE OR PREVENTIVE MAINTENANCE WOULD SHOW THIS TYPE OF WEAR AND DETERIORATION. A REVIEW OF THE SERVICE AND REPAIR DATABASE SHOWED NO OTHER SERVICE OR PREVENTIVE MAINTENANCE BEING PERFORMED BY MEDTRONIC FOR THE DEVICE IN QUESTION. THE CUSTOMER HAS BEEN ADVISED THAT THE ITEM IS OBSOLETE AND NON-REPAIRABLE. MEDTRONIC WILL NOTIFY THE FACILITY AND REQUEST THAT THE UNIT BE DISPOSED OF/DESTROYED BY MEDTRONIC. THE HAND PIECE IN QUESTION IS USED IN CONJUNCTION WITH A POWER CONSOLE. THE FACILITY HAS NOT INDICATED WHICH CONSOLE WAS BEING USED DURING THIS EVENT. LABELED WARNINGS HAVE BEEN INCLUDED FOR BOTH CONSOLES THAT MAY HAVE BEEN USED. XPS POWER CONSOLE IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: "WHEN NOT OPERATING THE HANDPIECE, ENSURE THAT HANDPIECE RESTS ON A NON-CONDUCTIVE SURFACE THAT PROVIDES CONTAINMENT FOR HANDPIECE AND BLADE/BUR. AVOID UNINTENDED THERMAL INJURY BY AN UNCONTAINED HAND PIECE." INTEGRATED POWER CONSOLE (IPC) IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: "DO NOT PLACE MOTOR, ATTACHMENT AND TOOL ON THE PATIENT OR IN AN UNSECURED LOCATION DURING SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDPIECE 1896200 STRAIGHTSHOT MAGNUM HRX MEDTRONIC XOMED INC. 1896200 26358300

    Patients

    Seq Age Sex Outcome Treatment
    1