BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHESTER ELECTRO-MEDICAL, INC.

    MDR report key: 491328 · Received July 22, 2003

    Report

    Report Number
    491328
    Event Type
    Injury
    Date Received
    July 22, 2003
    Date of Event
    June 18, 2003
    Report Date
    June 24, 2003
    Manufacturer
    ROCHESTER ELECTRO-MEDICAL, INC.
    Product Code
    GXZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 08/28/03: ROCHESTER ELECTRO-MEDICAL, INC. EVALUATED A SMALL PIECE OF ELECTRICAL WIRE. DIGITAL AND ANALOG PHOTOGRAPHS OF THE FRAGMENT WERE TAKEN AND DEVELOPED. THE PHOTOGRAPHS CLEARLY INDICATE THAT THE WIRE WAS CLEANLY CUT ON ONE END AND MANGLED ON THE OTHER END. THE FRAGMENT IS FROM THE MIDDLE OF THE WIRE CABLE, AND THERE WAS NO NEEDLE NOR TERMINATION IN EVIDENCE. NO OTHER PIECE WAS FOUND AT THE OPERATIVE SITE. THE WIRE DOES NOT APPEAR TO BE THE TYPE USED BY ROCHESTER ELECTRO-MEDICAL, INC. IN THE MFG OF ANY OF ITS PRODUCTS, SPECIFICALLY THE SUBDERMAL NEEDLE IN QUESTION. THE ROCHESTER ELECTRO-MEDICAL, INC. WIRE IS SPECIALLY PRODUCED EXLUSIVELY FOR ROCHESTER ELECTRO-MEDICAL, INC. THE WIRE IS 64 STRANDS OF #32 COPPER WIRE IN A PVC INSULATION JACKET. THE PHOTOGRAPHS CLEARLY SHOW 2 SEPARATED STRANDS OF WIRE PROTRUDING FROM THE BURNED INSULATION AND END WIRE COATING. THE TWO WIRE STRANDS ARE MUCH LARGER THAN THE INDIVIDUAL STRANDS OF CONDUCTOR WITHIN THE WIRE USED IN THE PRODUCT. THE LOT NUMBER OF THE SUBDERMAL NEEDLE USED IN THE SURGICAL PROCEDURE WAS 03110. THIS WOULD NOT HAVE BEEN POSSIBLE, BECAUSE THE SUBDERMAL NEEDLES IN LOT 03110 WERE NOT MFG AND STERILIZED UNTIL AFTER THE SURGERY. ADDITIONALLY, THE CO DOES NOT HAVE A RECORD OF THE MEDICAL CENTER HAVING PURCHASED ANY SUBDERMAL NEEDLES IN THE PAST TWO YEARS. THE SUBDERMAL NEEDLE HAD BEEN USED AS A GROUND DURING STIMULATION. IF THE NEEDLE WERE INSERTED BY A PHYSICIAN ONLY UNDER THE PT'S SKIN AS IS THE STANDARD INDUSTRY PROCEDURE FOR A SUBDERMAL NEEDLE, IT IS HIGHLY UNLIKELY THAT THE WIRE WOULD END UP INSIDE THE PT FOLLOWING THE PROCEDURE. ALSO, UNDER NORMAL USAGE, THERE WOULD NOT BE A BLACK RESIDUE ON THE WIRE NOR WOULD THE INSULATION APPEAR TO BE OBVIOUSLY BURNED. UPON EXAMINATION OF THE FRAGMENT AND AS SHOWN IN THE PHOTOGRAPHS, IT IS CLEAR THAT EXCESSIVE TRAUMA TO THE WIRE OCCURRED DURING THE PROCEDURE THAT WAS INCONSISTENT WITH NORMAL USAGE FOR THE PRODUCT. THE WIRE WAS CUT AND/OR BROKEN WITH UNUSUAL FORCE DURING OR FOLLOWING THE PROCEDURE. ALSO, ONE WOULD EXPECT THAT THE WIRE WOULD NOT BE SEVERED IN THE MIDDLE BUT RATHER ON THE END, LEAVING THE NEEDLE AND WIRE IN PLACE. THE CO CONCLUDES THAT THIS IS NOT THE CO'S PRODUCT, GIVEN THE UNUSUAL SIZE OF THE CONDUCTORS. THE LACK OF PURCHASE RECORDS ALSO POINTS TO THIS CONCLUSION. IF, THE PHYSICIAN DID NOT USE ANY OTHER WIRES DURING THE PROCEDURE, IT IS POSSIBLE THAT THE WIRE FRAGMENT WAS LEFT THERE FROM A PREVIOUS PROCEDURE. THE FDA CONDUCTED AN INSPECTION ON AUGUST 11,12 AND 14, 2003 AND CONCURRED WITH MFR FINDINGS. THEY THOROUGHLY EXAMINED THE PHOTOGRAPHS OF THE ALLEGED WIRE SEGMENT AND STATED THAT THE WIRE USED IN THE SURGICAL PROCEDURE AND THE ACTUAL WIRE USED IN THE MFG OF SUBDERMAL NEEDLES BY ROCHESTER ELECTRO-MEDICAL, INC WERE TOTALLY DIFFERENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR ON 09/18/03: THIS SIDE BY SIDE COMPARISON CLEARLY SHOWS TWO DIFFERENT TYPES OF WIRE AND WIRE STRANDING. THE SUBDURMAL WIRE THAT IS USED BY FACILITY IS SPECIAL ORDER WIRE CHOSEN FOR ITS HIGH STRANDING AND FLEXIBILITY PROPERTIES. FACILITY HAS NEVER USED ANY OTHER WIRE IN THEIR SUBDERMAL NEEDLES DATING BACK TO THE MID 1960'S.

    Description of Event or Problem · 1

    PT UNDER WENT UNCOMPLICATED TRANSFORAMENAL LUMBAR INTERBODY FUSION AT L4-5. RETURN TO SUGERY 36 DAYS LATER FOR SUCCESSFUL REMOVAL OF FOREIGN BODY & SMALL PIECE OF ELECTRICAL WIRE WITH RED INSULATION APPROX 1/4 INCH - FRAGMENT OF NEEDLE ELECTRODE USED IN ORIGINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHESTER ELECTRO-MEDICAL, INC. DISPOSABLE SUBDERMAL NEEDLE ELECTRODES GXZ ROCHESTER ELECTRO-MEDICAL, INC. REF# S0013315 27 GA., 12 MM. 03110

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R