BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

    MDR report key: 6327128 · Received February 13, 2017

    Report

    Report Number
    1045254-2017-00058
    Event Type
    Injury
    Date Received
    February 13, 2017
    Report Date
    January 18, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    UDI-DI
    00885074080932
    PMA / PMN Number
    K041413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: EC300 ¿ MASTER CONSOLE, LEGEND EHS; SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 64689100; MANUFACTURE DATE ¿ NOVEMBER 6, 2009; UDI ¿ (B)(4); 510K NUMBER - K081475 EF200 ¿ FOOT CONTROL, LEGEND EHS 3 BUTTON; SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 206351094; MANUFACTURE DATE ¿ NOVEMBER 15, 2012; UDI ¿ (B)(4); 510K - K081475. THE THREE DEVICES HAVE BEEN RECEIVED. THE PRODUCT ANALYSES HAVE NOT YET BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE USED DURING EVENT. A 1852000 (FOOTSWITCH, ENDO-SCRUB 2); SERIAL NUMBER - UNKNOWN; LOT NUMBER - UNKNOWN; UDI NUMBER - UNKNOWN; PMA 510K NUMBER - K902683. (B)(4) (MASTER CONSOLE, LEGEND EHS ¿ S/N (B)(4) ): THE PRODUCT ANALYSIS INDICATES THAT THE TOUCHSCREEN WAS CORRODED, THERE WERE BROKEN PINS FOUND IN THE FOOTSWITCH CONNECTOR PORT, AND THE DEVICE FAILED 2.5KV DIELECTRIC TEST. THE SOFTWARE WAS UPDATED. THE TOUCHSCREEN AND FRONT PANEL ASSEMBLY WERE REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATION. A 1898200T (M4 MICRODEBRIDER -S/N HP-(B)(4) ): THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE MOTOR SHOWED SIGNS OF LABORING AND THE MOTOR WAS CORRODED INSIDE THE HOUSING. THE DEVICE IS TO BE CLEANED AND TESTED TO SPECIFICATIONS. (B)(4) (FOOT CONTROO, LEGEND EHS ¿ S/N (B)(4): THE PRODUCT ANALYSIS INDICATES THAT THE CONNECTOR PINS WERE BROKEN OFF. THE CABLE ASSEMBLY WAS REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATION. A 1852000 (ENDO-SCRUB 2 FOOTSWITCH ¿ S/N UNKNOWN): THE PRODUCT ANALYSIS INDICATES THAT THERE WERE MULTIPLE LESIONS AND EXPOSED WIRES FOUND. DUE TO THE NATURE OF THE DAMAGE, THE FOOTSWITCH COULD NOT BE REPAIRED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 WHILE THE SURGEON WAS USING THE M4 HANDPIECE, HE RECEIVED A SMALL SHOCK. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THE SURGEON DID NOT REQUIRE MEDICAL ATTENTION DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108007 IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC. 1898200T 206486956 00885074080932

    Patients

    Seq Age Sex Outcome Treatment
    1 Other