BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDPIECE 1897200 MAGNUM II HI SPEED EN

    MDR report key: 2539929 · Received April 18, 2012

    Report

    Report Number
    1045254-2012-00182
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    K002224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. EVALUATION WAS PERFORMED BY THE QUALITY ENGINEERING TEAM. BLUE RESIDUE WAS SEEN ON THE HANDPIECE WHERE THE DRAPE HAD MELTED ONTO THE HANDPIECE BODY. THE HANDPIECE WAS PLUGGED INTO A POWERED-ON IPC CONSOLE FIXTURE IN SERVICE AND REPAIR. AN ERROR CODE 15 WAS DISPLAYED ON THE CONSOLE WHEN THE HANDPIECE WAS PLUGGED IN. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE IPC ((B)(4)), ERROR CODE 15 INDICATES "HANDPIECE STALLED." THE HANDPIECE COULD NOT BE POWERED ON OR RUN DURING THE EVALUATION. IT IS POSSIBLE FOR THE HANDPIECE MOTOR TO BECOME STALLED DUE TO DAMAGE RELATED TO OVERHEATING. BECAUSE OF THIS AND THE BLUE RESIDUE ON THE HANDPIECE, THE COMPLAINT IS CONSIDERED CONFIRMED. THE M2 HANDPIECE CAN BE RUN ON THE IPC CONSOLE OR THE XPS 3000 CONSOLE. IFU'S FOR BOTH THE IPC AND XPS 3000 INCLUDE WARNINGS INDICATING TO KEEP THE HANDPIECE IN A SECURED LOCATION AT ALL TIMES. THE IPC INSTRUCTIONS FOR USE WARNS: DO NOT PLACE MOTOR, ATTACHMENT AND TOOL ON THE PATIENT OR IN AN UNSECURED LOCATION DURING SURGERY. BEFORE SURGERY WHEN NOT OPERATING 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 HANDPIECE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT PURPOSES. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. (B)(4). THE DEVICE HAS BEEN RETAINED BY THE USER FACILITY FOR EVALUATION AND HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME. METHOD: (B)(4). RESULTS: (B)(4). CONCLUSION: (B)(4) [WARNING INDICATED IN THE PRODUCT LABELING INSTRUCTIONS FOR USE]. INDICATIONS FOR USE: THE STRAIGHTSHOT MAGNUM II HANDPIECE IS A COMPONENT USED IN CONJUNCTION WITH THE INTEGRATED POWER CONSOLE SYSTEM (IPC). SINUS INDICATIONS INCLUDE SEPTOPLASTY, REMOVAL OF SEPTAL SPURS, POLYPECTOMY, ANTROSTOMY, ETHMOIDECTOMY/SPHENOETHMOIDECTOMY, FRONTAL SINUS TREPHINATION AND IRRIGATION, FRONTAL SINUS DRILL OUT, ENDOSCOPIC DCR, TRANS-SPHENOIDAL PROCEDURES, MAXILLARY SINUS POLYPECTOMY, CIRCUMFERENTIAL MAXILLARY ANTROSTOMY, CHOANAL ATRESIA, SPHENOIDECTOMY, AND MEDIAL, LATERAL, AND POSTERIOR FRONTAL SINUSOTOMY. NASOPHARYNGEAL/LARYNGEAL INDICATIONS INCLUDE ADENOIDECTOMY, TRACHEAL PROCEDURES, LARYNGEAL POLYPECTOMY, LARYNGEAL LESION DEBULKING, TONSILLECTOMY, TONSILLOTOMY FOR OBSTRUCTIVE TONSILLAR DISEASE, REMOVAL OF ENDOBRONCHIAL LESIONS AND SURGICAL MANAGEMENT OF RECURRENT RESPIRATORY PAPILLOMATOSIS (RRP). DEVICE DESCRIPTION: THE IPC SYSTEM IS A POWERED MICRODEBRIDER, DRILL AND SAW SYSTEM THAT WILL REMOVE SOFT TISSUE, HARD TISSUE AND BONE DURING SURGICAL PROCEDURES. THE SYSTEM CONSISTS OF A POWER CONTROL CONSOLE, FOOTPEDAL, CONNECTION CABLES AND ASSORTED HANDPIECES TO DRIVE VARIOUS BURS, BLADES, DRILLS, RASPS, CANNULAE AND SAWS. IT INCLUDES INTEGRATED IRRIGATION PUMPS FOR IRRIGATION OF BLADES, BURS AND FOR MOTOR COOLANT. COMPONENT WARNINGS: DO NOT PLACE MOTOR, ATTACHMENT AND TOOL ON THE PATIENT OR IN AN UNSECURED LOCATION DURING SURGERY. DO NOT USE AN OVERHEATED DEVICE, AS IT MAY CAUSE THERMAL INJURY TO THE PATIENT OR OPERATOR. USE ADEQUATE IRRIGATION. THE USE OF A TOOL WITHOUT IRRIGATION MAY CAUSE AN INORDINATE AMOUNT OF HEAT BUILDUP RESULTING IN A THERMAL INJURY TO TISSUE. DEPENDING ON THE AMOUNT OF IRRIGATION USED THE DRILL BITS AND SAW BLADES CAN ACHIEVE TEMPERATURES IN EXCESS OF 50°C.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERVAL USE OF THE HANDPIECE IN SINUS SURGERY, THE DEVICE WAS PLACED ON THE PATIENT. SMOKE WAS OBSERVED TO BE COMING FROM THE STERILE DRAPE. THE HANDPIECE WAS PICKED UP AND IT WAS FOUND TO BE HOT AND HAD SUBSEQUENTLY RESULTED IN SECOND DEGREE BURNS TO THE PATIENT IN THE UPPER ABDOMEN BELOW THE LEFT RIB. THE BURN MEASURED APPROXIMATELY 6MM X 3MM. IT WAS NOTED THAT THE SURGEON "CUT OUT" THE BURNED TISSUE DURING SURGERY TO MINIMIZE SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDPIECE 1897200 MAGNUM II HI SPEED EN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1897200 52603400

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Required Intervention