BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTION SYSTEM

    MDR report key: 3966160 · Received June 25, 2014

    Report

    Report Number
    2183456-2014-00005
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    IKD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FEEDBACK OF THE CABLE CONCERN WAS PROVIDED TO AD-TECH ON (B)(4) 2014. DURING THE INVESTIGATION OF THE COMPLAINT, ON (B)(4) 2014 AD-TECH WAS MADE AWARE OF A 30 MINUTE DELAY IN THE SURGICAL PROCEDURE. THE DELAY IN THE SURGICAL PROCEDURE DUE TO THE CABLE DEFECT IS THE REPORTED EVENT THAT TRIGGERED THE MDR. AD-TECH RECEIVED THE TWO IMPACTED CABLES FROM THE CUSTOMER ON (B)(4) 2014. A VISUAL INSPECTION AND CONTINUITY ANALOG/DIGITAL TESTING WERE PERFORMED THAT SAME DAY ON THE CABLES. BASED ON THE RESULTS, THE RETURN EVALUATION DOES SUPPORT THE ALLEGED DEFICIENCY REPORTED IN THE COMPLAINT AS IT WAS FOUND THAT THE VISUAL INSPECTION FAILED ON BOTH CABLES DUE TO THE CABLES SHOWING EVIDENCE OF INCORRECT STERILIZATION APPLIED BY THE END-USER AND THE CONTINUITY TESTING FAILED ON BOTH CABLES DUE TO CHANNELS HAVING CROSS CONNECTION. ON (B)(4) 2014, IT WAS CONFIRMED THAT THE CUSTOMER DID NOT STERILIZE THE CABLES PER AD-TECH MEDICAL'S DIRECTIONS FOR USE (DFU). THE DFU STATES, "STERILIZING: THE TECH-ATTACH CABLES CAN BE STERILIZED USING ETHYLENE OXIDE (EO) OR STERRAD". THE CUSTOMER CONFIRMED THAT THE CABLES WERE STERILIZED VIA AUTOCLAVE AT 134 CELSIUS DEGREES. THE CUSTOMER APPLICATION OF AUTOCLAVE STERILIZATION IS A PROBABLE CAUSE OF THE CABLE FAILURE. THE CUSTOMER HAS BEEN REMINDED TO APPLY RECOMMENDED STERILIZATION PROCESSES TO THE CABLES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO AD-TECH THAT TWO CABLES" WERE FAULTY, NEARLY ALL WIRES IS SHORTED" SURGERY WAS DELAYED FOR HALF AN HOUR AND RECORDING WAS DELAYED LONGER BECAUSE OF THE CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369572 CONNECTION SYSTEM 12 CONTACT TECH-ATTACH CABLE IKD AD-TECH MEDICAL INSTRUMENT CORP. 310290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other