BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDX

    MDR report key: 9557236 · Received January 7, 2020

    Report

    Report Number
    3014579024-2020-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    November 21, 2019
    Report Date
    February 26, 2020
    Manufacturer
    HUMAN XTENSIONS LTD.
    Product Code
    GCJ
    UDI-DI
    07290017376049
    PMA / PMN Number
    K173919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED TO ASSESS THE CAUSE AND POTENTIAL IMPACT OF THE OBSERVED ABSENCE OF ADHESIVE ON THE DEVICE COMPONENTS. NO CONCLUSIVE ROOT CAUSE WAS IDENTIFIED, BUT SPECIFIC MANUFACTURING PROCESSES, SUCH AS NON-UNIFORM ADHESIVE ON THE BELLOW SURFACE, MANUAL GLUING OPERATIONS, AND POTENTIALLY AMBIGUOUS ASSEMBLY INSTRUCTIONS, MAY HAVE CONTRIBUTED TO THE MALFUNCTION. THESE TESTS ALSO INCLUDED A RE-ASSESSMENT OF THE RISK RELATED TO THE REPORTED MALFUNCTION. A TEST FOR EMC COMPLIANCE PER IEC 60601-1-2 WAS CONDUCTED, EXPOSING THE DEVICE INNER PARTS AT THE TEST LABORATORY OF THE STANDARDS INSTITUTION OF ISRAEL (SII). THE TEST DEMONSTRATED THAT THERE IS NO IMPACT ON THE ESSENTIAL PERFORMANCE OF THE DEVICE EVEN WHEN EXPOSING THE INNER PARTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION:THE MALFUNCTION OCCURED IN POLAND.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE HANDPIECE CONTROL INTERFACE " FLEXIBLE BACK PART LOCKED OR WORKING TOO HARD TO OPERATE AFTER APPROX. 16-60 MINUTES." IN THE VISUAL INSPECTION PERFORMED BY THE DISTRIBUTOR IT WAS OBSERVED THAT THE GLUE INTEGRITY WAS COMPROMISED. ON DEC 18 AND 19, 2019 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DESCRIBED MALFUNCTION OCCURRED DURING MARKETING DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24855 HANDX ELECTROMECHANICAL MOTORIZED LAPAROSCOPIC DEVICE GCJ HUMAN XTENSIONS LTD. NA NA 07290017376049

    Patients

    Seq Age Sex Outcome Treatment
    1