BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 7061794 · Received November 27, 2017

    Report

    Report Number
    1045834-2017-50024
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Report Date
    October 30, 2017
    Manufacturer
    THE ANSPACH EFFORT LLC
    Product Code
    HBE
    UDI-DI
    00845384004356
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS AND IDENTIFIED NO FAILURE. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE ATTACHMENT DEVICE BECAME UNUSUALLY WARM. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837875 MINIMAL ACCESS ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT HBE THE ANSPACH EFFORT LLC MA-D20 N/A 00845384004356

    Patients

    Seq Age Sex Outcome Treatment
    1