BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR 8562010 VARI-STIM III 10PK

    MDR report key: 2474679 · Received March 1, 2012

    Report

    Report Number
    1045254-2012-00037
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 3, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE INFORMATION REASONABLY SUGGESTS THAT THE DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA, AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT INFORMATION TO REASONABLY SUGGEST A SERIOUS INJURY OR MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THREE SAMPLES WERE RETURNED IN A (B)(6) BAG WITH NO ORIGINAL PACKAGING OR LABELING. A CUSTOMER PACKING SLIP INDICATED THE IDENTITY OF THE SAMPLES AS ITEM 8562010 FROM LOT # 0205312453. PRINT ON THE SIDE OF THE SAMPLES ALSO IDENTIFIED THE UNITS AS VARI-STIM III. THE COMPLAINT ALLEGES THAT "FOUR UNITS DID NOT WORK DURING THE CASE - TWO HAD NO LIGHT(S) AND TWO HAD NO STIMULATION DESPITE THE LIGHT(S) BEING ON." AS THERE IS NO WAY TO TELL WHICH SAMPLES WENT WITH WHICH FAILURE MODE, ALL THREE PRODUCT OBSERVATIONS WILL BE SUMMARIZED HERE. ALL THREE SAMPLES HAD TIPS WHICH HAD BEEN ALTERED, AND BENT BEYOND SPECIFICATION. THE VARI-STIM IIIS ARE DISTRIBUTED WITH THE TIPS BENT AT A 20 DEGREE ANGLE, PER DRAWING (B)(4). THE IFU SPECIFIES "DO NOT BEND THE PROBE TIP AS THE DEVICE MAY BECOME DAMAGED AND MALFUNCTION." THE IFU ALSO STATES "DURING SURGERY, A LIT LED CONFIRMS DELIVERY OF CURRENT. IF LED IS NOT ACTIVATED INTRAOPERATIVELY, THE DEVICE CAN BE TESTED BY TOUCHING THE PROBE TIP TO THE NEEDLE ELECTRODE." THIS FUNCTIONAL TEST WAS REPEATED ON EACH OF THE RETURNED SAMPLES. IN ADDITION, TESTING FOR INTERMITTENCY WAS PERFORMED BY TURNING THE SWITCH THROUGH THE RANGE OF PLAY. ANOTHER STATEMENT WITHIN THE IFU IS "TO ENSURE CONTINUED FUNCTIONALITY, RE-TEST AFTER CHANGING THE CURRENT SETTING." PEN TRACES WERE TAKEN OF THE BENT TIPS AND THE RESULTANT ANGLES WERE MEASURED WITH PROTRACTOR (B)(4)(CAL DUE (B)(6) 2012). PER DRAWING - SAMPLE 1 WAS RECEIVED SET TO 2.0MA. THE FUNCTIONAL TEST WAS PERFORMED AND THE LED WAS LIT. RESISTANCE READINGS WERE TAKEN WITH A CALIBRATED FLUKE 21 MULTIMETER ((B)(4)) FROM THE TIP OF THE PROBE TO THE NEEDLE. THE FOLLOWING READINGS WERE OBTAINED: SETTING READING LED ACTIVATED: 2.0MA 2.01MA YES 1.0MA 1.04MA YES 0.5MA 0.51MA YES NO INTERMITTENCY OF CONTINUITY WAS DETECTED. THE ANGLE OF THE BENT TIP WAS MEASURED AT 70 DEGREES. SAMPLE 2 WAS RECEIVED NOT SET TO ANY POSITION, BUT RATHER BETWEEN 0.5MA AND 2.0 MA SETTINGS. IN THIS POSITION, THE UNIT DID NOT PASS THE FUNCTIONAL TEST. (LED DID NOT LIGHT.) THE FOLLOWING READINGS WERE OBTAINED: SETTING READING LED ACTIVATED: 2.0MA 2.05MA YES 1.0MA 1.02MA YES 0.5MA 0.50MA YES NO INTERMITTENCY OF CONTINUITY WAS DETECTED. THE ANGLE OF THE BENT TIP WAS MEASURED AT 56 DEGREES. SAMPLE 3 WAS RECEIVED SET TO THE 2.0MA SETTING, AND IT PASSED THE FUNCTIONAL TEST IN THIS POSITION. THE FOLLOWING READINGS WERE OBTAINED: SETTING READING LED ACTIVATED: 2.0MA 2.09MA YES 1.0MA 1.05MA YES 0.5MA 0.51MA YES NO INTERMITTENCY OF CONTINUITY WAS DETECTED. THE ANGLE OF THE BENT TIP WAS MEASURED AT 74 DEGREES. THE COMPLAINT CANNOT BE REPRODUCED, AND IS UNCONFIRMED. DUE TO THE OBVIOUS ALTERATION DONE TO THE TIPS OF THE PROBES, USER ERROR IS INDICATED. THE VARI-STIM III NERVE STIMULATOR IS A BATTERY POWERED LOCATOR WITH CONTINUOUS OUTPUT CURRENT ADJUSTABLE TO APPROXIMATELY 0.5MA, 1.0MA, AND 2.0MA. A SUBCUTANEOUS (POSITIVE GROUND) NEEDLE ELECTRODE IS ATTACHED. THE LED LIGHT IS USED TO TEST THE DEVICE. THE DEVICE IS INTENDED FOR THE STIMULATION OF EXPOSED MOTOR NERVES OR MUSCLE TISSUE TO LOCATE AND IDENTIFY NERVES AND TO TEST NERVE EXCITABILITY. THE DEVICE IS NOT INDICATED FOR THE USE WHEN PARALYZING ANESTHETIC AGENTS ARE BEING USED AS THEY WILL SIGNIFICANTLY REDUCE, IF NOT COMPLETELY ELIMINATE, EMG RESPONSES TO DIRECT OR PASSIVE NEURAL STIMULATION.

    Additional Manufacturer Narrative · 1

    PMA/510K: PRE-AMENDMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SCHEDULED PAROTIDECTOMY THERE WERE FOUR NERVE STIMULATORS THAT DID NOT WORK ON AN EXPOSED NERVE. TWO NERVE STIMULATORS DID NOT LIGHT, AND ALL FOUR STIMULATORS FAILED TO STIMULATE THE NERVE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULATOR 8562010 VARI-STIM III 10PK STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8562010 0205312453

    Patients

    Seq Age Sex Outcome Treatment
    1