BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM STERILE TUBE DRAPE - 20 PACK

    MDR report key: 3120879 · Received May 20, 2013

    Report

    Report Number
    1723170-2013-00308
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    KKX
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE WAS UNABLE TO PROVIDE ANY PATIENT DEMOGRAPHIC INFORMATION.THE INITIAL REPORT WAS RECEIVED ON 11/10/2010 AND INCORRECTLY FOUND TO BE A NON-REPORTABLE MALFUNCTION BASED ON THE INFORMATION AVAILABLE. ON 05/02/2013, A RETROSPECTIVE REVIEW WAS CONDUCTED THAT IDENTIFIED THIS EVENT AS REPORTABLE AND THE DECISION WAS REVERSED TO A REPORTABLE MALFUNCTION.MANUFACTURE DATE WAS UNAVAILABLE AS NO LOT NUMBER WAS PROVIDED.NO PARTS OR FILES WERE RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE USER COVERED THE TEAR WITH AN IOBAN TO RETAIN STERILITY WITH NO PATIENT IMPACT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO ADDRESS THIS REPORTED FAILURE MODE AND RESOLVE THE ISSUE. PER THE SCAR, THE SUPPLIER'S INVESTIGATION FOUND THAT THE LABEL WAS PLACED INCORRECTLY ON FOLDED LAYERS OF THE DRAPE. THE ROOT CAUSE WAS FOUND TO BE OPERATOR ERROR. A CORRECTION AT THE SUPPLIER WAS IMPLEMENTED BY ADDING A CRITICAL NOTE TO THE SPECIFICATION INDICATING PROPER PLACEMENT OF THE LABEL. IN ADDITION, SUPPLIER PERSONNEL WERE RETRAINED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE O-ARM DRAPES GOT CAUGHT ON THE CORNERS AND TORE DURING A SURGERY, THEY THEN COVERED THE BREACH WITH IOBAN. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222098 O-ARM STERILE TUBE DRAPE - 20 PACK DRAPE, SURGICAL KKX MEDTRONIC NAVIGATION, INC. (LITTLETON)

    Patients

    Seq Age Sex Outcome Treatment
    1