BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMALLY INVASIVE SPINE SYSTEM

    MDR report key: 2781225 · Received October 10, 2012

    Report

    Report Number
    0002242816-2012-00070
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    EBI, LLC.
    Product Code
    FDG
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.THIS IS 1 OF 3 MDRS INVOLVED IN THE SAME EVENT. PLEASE SEE MDR NUMBERS:0002242816-2012-00068,0002242816-2012-00069,0002242816-2012-00070.

    Additional Manufacturer Narrative · 1

    THE DEVICE DISCARDED AND THEREFORE AN EVALUATION COULD NOT BE PERFORMED. DUE TO THE INABILITY TO EVALUATE DEVICE ASSOCIATED WITH THE REPORTED EVENT, WE ARE UNABLE TO PROVIDE A DETAILED ANALYSIS FOR THE INSTRUMENTATION. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO DIMENSIONAL, FUNCTIONAL, OR MATERIAL ANOMALIES FOUND IN THE DOCUMENTATION. THE MOST PROBABLY ROOT CAUSE FOR THE REPORTED EVENT IS INCORRECT CONNECTION TO UNAPPROVED LIGHT SOURCE. AS REPORTED, THE SYSTEM WAS INCORRECTLY ATTACHED TO A KARL STORZ LIGHT SOURCE. ACCUVISION ONLY COMES WITH AN ACMI ADAPTER. ACCORDING TO THE REFERENCE GUIDE AND SURGICAL TECHNIQUE: "ACCUVISION LIGHTED BLADE TIPS ARE STERILE PACKED WITH A STANDARD ACMI ADAPTER. A STERILIZED LIGHT CABLE NEEDS TO BE SUPPLIED BY THE OPERATING ROOM TO CONNECT TO THE O.R. SUPPLIED LIGHT SOURCE. DO NOT CONNECT THE LIGHTED BLADE TIP DIRECTLY TO THE LIGHT SOURCE." "THE ACCUVISION ILLUMINATED BLADE TIP IS INTENDED FOR USE WITH A 300 WATT XENON ILLUMINATOR, USING A 3.0MM FIBER OPTIC CABLE WITH A FEMALE ACMI CONNECTOR." "THE ACCUVISION ILLUMINATED BLADE TIP CONNECTS TO A LIGHT SOURCE USED FOR HEAD LAMPS OR ENDOSCOPES. A 3.0MM FIBER OPTIC CABLE WITH AN ACMI FITTING ATTACHES THE LIGHT SOURCE AND ACCUVISION ILLUMINATED BLADE TIP. MAKE SURE THE LIGHTED BLADE CONNECTOR IS SECURELY ATTACHED TO THE CABLE. THE CABLE SHOULD BE IN GOOD REPAIR WITH CLEAN OPTICS. DIRTY OPTICS OR CABLES IN NEED OF REPAIR CAN CAUSE EXCESSIVE HEAT AT THE CONNECTORS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROBLEMS WITH THE LIGHT SOURCE OF THE MINIMALLY INVASIVE SPINE SYSTEM CAUSED A 30 MINUTE DELAY IN SURGERY.PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMALLY INVASIVE SPINE SYSTEM ACCUVISION BLADE TIP - FLAT FDG EBI, LLC. N/A 833310

    Patients

    Seq Age Sex Outcome Treatment
    1