BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER SURGICAL PLATFORM

    MDR report key: 2323082 · Received October 17, 2011

    Report

    Report Number
    3007593944-2011-00008
    Event Type
    Malfunction
    Date Received
    October 17, 2011
    Date of Event
    September 15, 2011
    Report Date
    October 18, 2011
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    OTJ
    PMA / PMN Number
    K102839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION PERFORMED WAS INTENDED TO EVALUATE THE MANUFACTURING PROCESS FOR DEFECTS AND ATTEMPT TO RECREATE THE FAILURE. FIRST THE COMPANY QA UNIT REVIEWED AND WITNESSED THE MANUFACTURING PROCESS TO EVALUATE WHETHER DEFECTS MIGHT HAVE BEEN INTRODUCED INTO THE SHEATH. OTHER SHEATH INVENTORY WAS CHECKED FOR POSSIBLE DEFECTS TO ATTEMPT TO IDENTIFY A ROOT CAUSE. NO CAUSE FOR THE FAILURE MODE RELATED TO MANUFACTURING COULD BE IDENTIFIED. BECAUSE THE DEVICE WS NOT RETURNED AND THE DESCRIPTION OF THE FAILURE MODE WAS SO UNUSUAL, THE COMPANY ATTEMPTED TO 'RECREATE' THE FAILURE MODE BY REPEATING THE STEPS USED BY THE SURGEON AS RECOUNTED BY THE SURGICAL SALES REP. THE ACTUAL FAILURE COULD NOT BE REPRODUCED. THERE HAVE NEVER BEEN ANY OTHER SIMILAR FAILURES EITHER WITHIN VERIFICATION AND VALIDATION TESTING OR FROM OTHER CUSTOMER COMPLAINTS. IT IS SURMISED THAT THE SURGEON 'ROLLED UP' THE SHEATH WITHIN A SEPARATE TROCAR AND THEN TRIED TO PUSH THE SPIDER DEVICE INTO THE OPENING, POSSIBLY TANGLING THE INSTRUMENT DELIVERY TUBES WITHIN THE SHEATH, THEREBY STRETCHING AND TEARING THE SHEATH.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GASTRIC BAND PROCEDURE, A RETRACTION SHEATH WAS TORN APART. IT IS NOTED THAT THE DEVICE WAS USED INCORRECTLY, OUTSIDE THE LABELED INSTRUCTIONS FOR USE. THE SURGEON ELECTED TO USE THE RETRACTION SHEATH AS AN INTRODUCTION SHEATH. INVESTIGATION HAS INDICATED THAT THE SURGEON PURPOSEFULLY CHOSE TO USE THE RETRACTION SHEATH FOR INSERTION. THE SURGEON WAS ABLE TO RETRIEVE THE TORN SHEATH AND ALL PARTS WERE ACCOUNTED FOR. NO INJURY OR IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER SURGICAL PLATFORM OTJ, LAPAROSCOPIC SINGLE PORT ACCESS OTJ TRANSENTERIX, INC. 9000020 G2L TX195111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK