BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE MAXCESS LIGHT GUIDE

    MDR report key: 12021689 · Received June 17, 2021

    Report

    Report Number
    2031966-2021-00078
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 17, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    FST
    UDI-DI
    00887517074973
    PMA / PMN Number
    K042034
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. DUE TO LACK OF INFORMATION PROVIDED NO ROOT CAUSE COULD BE IDENTIFIED. HOWEVER REVIEW OF THE REPORTED INFORMATION SUGGESTS LIGHT TIP CAPS THAT ARE PART OF PACKAGING WERE NOT REMOVED PRIOR TO USE. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABELING REVIEW: "WARNINGS, CAUTIONS AND PRECAUTIONS: SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN USING ELECTRICAL EQUIPMENT TO PREVENT OPERATOR/PATIENT SHOCK, FIRE HAZARD, OR EQUIPMENT DAMAGE. FIRE HAZARD: DO NOT DRAPE OR COVER THE LIGHT SOURCE OR THE MAXCESS LIGHT CABLE WHILE IT IS OPERATING. DO NOT PLACE THE LIGHT CABLE ON THE DRAPE WHILE IT IS OPERATING. LIGHT SOURCES USE HIGH INTENSITY LAMPS, WHICH PRODUCE HEAT AS WELL AS BRILLIANT LIGHT. THE HIGH BRIGHTNESS PRODUCED BY THE LIGHT SOURCE AND THE LIGHT OUTPUT OF THE LIGHT CABLE CAN CAUSE SERIOUS BURNS. TAKE PRECAUTIONS NOT TO TOUCH OR DISCONNECT THE CABLE END FITTING FROM THE TURRET UNTIL THE LIGHT SOURCE HAS BEEN SHUT DOWN FOR A PERIOD OF TIME AND ALLOWED TO COOL. THE CABLE FITTING WILL REMAIN HOT IMMEDIATELY FOLLOWING SHUTDOWN, WHICH CAN CAUSE BURNS. TAKE PRECAUTIONS TO NOT PLACE AND REST A HOT CABLE END FITTING AND OR HEAD LIGHT ON A PATIENT OR ALLOW THE SYSTEM TO COME IN CONTACT WITH UN-PROTECTED HANDS OR TISSUE. THE ENTIRE SYSTEM SHOULD BE ALLOWED TO COOL FOLLOWING USE. FAILURE TO DO SO CAN CAUSE BURNS AND/OR TISSUE DAMAGE." "PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND INJURY TO THE PATIENT." "METHOD OF USE: IF THERE IS ANY DOUBT OR UNCERTAINTY CONCERNING THE PROPER USE OF INSTRUMENTS PLEASE CONTACT NUVASIVE CUSTOMER SERVICE. ANY AVAILABLE SURGICAL TECHNIQUES WILL BE PROVIDED UPON REQUEST. STEP 1: REMOVE MAXCESS LIGHT CABLE ASSEMBLY FROM STERILE PACKAGE. STEP 2: REMOVE PROTECTIVE TIP COVERS FROM MAXCESS LIGHT CABLE ASSEMBLY. STEP 3: WHEN USING LIGHT CABLE PART NUMBERS 1025461, 1577130, OR 1589263, INSTALL APPROPRIATE LIGHT SOURCE ADAPTER SUPPLIED WITH THE NUVASIVE RETRACTOR SYSTEM E.G., MAXCESS ACCESS SYSTEM. STEP 4: INSERT MAXCESS LIGHT CABLE ASSEMBLY INTO LIGHT SOURCE. STEP 5: WHEN USING LIGHT CABLE PART NUMBERS 1025461, 1577130, OR 1589263, INSERT THE TIPS ROUNDED SIDE TOWARD THE BLADE INTO THE BLADES OF THE RETRACTOR AND ADJUST TO THE DESIRED DEPTH. WHEN USING LIGHT CABLE PART NUMBER 3900000, INSERT THE TIPS INTO THE BLADES OF THE RETRACTOR UNTIL BOTTOMING OUT. STEP 6: WHEN USING LIGHT CABLE PART NUMBERS 1025461, 1577130, OR 1589263, ONCE THE DESIRED DEPTH IS ACHIEVED, BEND THE LIGHT TIPS OUT AND AWAY FROM THE ACCESS CORRIDOR."

    Description of Event or Problem · 1

    A BURNING SMELL WAS NOTICED COMING FROM A DISPOSABLE ITEM THAT WAS BURNING AT THE TIP INSIDE THE NUVASIVE MAXCESS LIGHT GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913573 NUVASIVE MAXCESS LIGHT GUIDE LIGHT, SURGICAL, FIBEROPTIC FST NUVASIVE, INCORPORATED 1025461 00887517074973

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR