BEUDAMED
    FDA Adverse Event Other Summary report: N

    DFLEX 45CM BIG D RETRACTOR

    MDR report key: 5310752 · Received September 15, 2004

    Report

    Report Number
    1038548-2004-00025
    Event Type
    Other
    Date Received
    September 15, 2004
    Date of Event
    August 17, 2004
    Report Date
    September 15, 2004
    Manufacturer
    CARDINAL HEALTH (SNOWDEN PENCER)
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INSTRUMENT WAS EVALUATED BY ENGINEERING, MANUFACTURING AND QA. BOTH SIDED OF THE CABLE BROKE AT THE INTERFACE BETWEEN THE RIGID SHAFT AND THE SEGMENTS. THE NITINOL WIRE WAS PERMANENTLY DEFORMED AT THE SAME JUNCTION. THE HOLES AT THE END OF THE RIDID SHAFT AND THE HOLES ON THE SEGMENT FACING THE RIGID SHAFT HAVE WEAR THAT INDICATES THE CABLE WAS TWISTED APPROXIMATELY 180 DEGREES. THE CABLE FAILURE AND THE DEFORMATION OF THE NITINOL WIRE WERE MOST LIKELY CAUSED BY MISHANDLING. DURING REPROCESSING, THE FLEXIBLE PORTION OF THE UNIT WAS PROBABLY BENT AT A RIGHT ANGLE INTO A STERILIZING TRAY WITHOUT THE PROTECTIVE SLEEVE OVER THE FLEXIBLE PORTION AS IS DESCRIBED IN THE INSTRUCTION BOOKLET. NITINOL IS A SUPER-ELASTIC MATERIAL THAT CAN WITHSTAND REPEATED GRADUAL BENDING. IF IT IS BENT SHARPLY, IT WILL PERMANENTLY DEFORM AND SNAP. DURING SURGERY, THE UNIT PROBABLY COULD NOT FORM ITS D-SHAPE BECAUSE THE CABLE WAS TWISTED DROM THE DEFORMED NITINOL. THE CABLE SNAPPED DUE TO EXCESSIVE STRESS AT ONE LOCATION. NO CAPA IS REQUIRED BECAUSE THE FAILURE WAS MOST LIKELY CAUSED BY CUSTOMER MISHANDLING. THERE ARE NO SIMILAR COMPLAINTS REGARDING THIS MODEL. TRENDING WILL BE MONITORED.

    Description of Event or Problem · 1

    PARTS OF THE RETRACTOR FELL INTO THE PT WHEN THE CABLE BROKE. THE TIP WAS RETRIEVED LAPAROSCOPICALLY. X-RAY WAS DONE, NO PIECES REMAIN IN THE PT PER THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DFLEX 45CM BIG D RETRACTOR NONE GCJ CARDINAL HEALTH (SNOWDEN PENCER) 89-6216 780873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other