BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPOSE 4 DEVICE

    MDR report key: 2160254 · Received June 2, 2011

    Report

    Report Number
    2242352-2011-00575
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    March 25, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED NO NON CONFORMITIES WITH THE RETURNED DEVICE. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. A FUNCTIONAL TEST WAS PERFORMED TO TEST THE MOUNT LEVER. WHEN THE MOUNT LEVER WAS PULLED BACK, IT SUCCESSFULLY MOUNTED ON THE BLADES. AN ADDITIONAL TEST WAS PERFORMED TO DETERMINE IF THE XPOSE 4 DEVICE WOULD TIGHTEN OR NOT. THE KNOB TURNED FREELY AND DID NOT TIGHTEN. BASED UPON THESE FINDINGS, THE REPORTED COMPLAINT "COULD NOT BE ATTACHED TO THE RETRACTOR" COULD NOT BE CONFIRMED BUT THE COMPLAINT WAS CONFIRMED FOR "KNOB NOT TIGHTENING." A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE XPOSE 4 DEVICE COULD NOT BE ATTACHED TO THE RETRACTOR. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPOSE 4 DEVICE XPOSE 4 DEVICE MWS MAQUET CARDIOVASCULAR, LLC XP-4000 25016361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA