BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITE GLOVE

    MDR report key: 6849805 · Received September 7, 2017

    Report

    Report Number
    1282497-2017-05336
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 8, 2017
    Report Date
    February 7, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REGARDING THE PRODUCT EVENT. ONE SAMPLE WAS RECEIVED AND A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED AND THE REPORTED ISSUE WAS NOT CONFIRMED. THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THIS COMPLAINT WILL BE CONSIDERED AS UNCONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED AS IT WAS UNKNOWN WHICH ADAPTER MODEL WAS USED DURING THE PROCEDURE. FOR ALL LOTS PRODUCED, THE SUPPLIER PERFORMS INCOMING INSPECTION AND VERIFIES THAT THE MATERIAL MEETS RETENTION AND INSTALLATION FORCE ACCEPTANCE CRITERIA. AS PART OF CONTINUOUS IMPROVEMENT EFFORTS AND A CORRECTIVE ACTION, THE SUPPLIER CHANGED THE INSPECTION MEASUREMENT TECHNIQUE FROM GO / NO GO GAUGING TO USING A PULLING / INSERT FORCE TEST. QUALITY WILL CONTINUE TO MONITOR THIS ISSUE THROUGH INCOMING INSPECTION AND COMPLAINTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE INVESTIGATION WILL RESUME AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT A PATIENT WAS IN THE ROOM WHEN THE LITE GLOVE FELL OFF. THE FALLEN GLOVE WAS TAKEN OFF OF THE PATIENT AND A NEW GLOVE WAS PLACED. THE CUSTOMER FURTHER REPORTS THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE LIGHT COVERS WERE FALLING OFF OF THE LIGHT HANDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630524 LITE GLOVE FTA COVIDIEN LT-F01B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1