BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FLEXIBLE GRASPER

    MDR report key: 2566573 · Received May 4, 2012

    Report

    Report Number
    3007593944-2012-00004
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    March 29, 2012
    Report Date
    May 3, 2012
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS EVENT OCCURRED OUTSIDE THE U.S. IN (B)(4) IT WAS NOT CLEAR AS TO WHETHER THIS EVENT REQUIRED REPORTING AS IT IS AN EXPORTED PRODUCT THAT IS ALSO SOLD IN THE U.S. LEGAL COUNSEL WAS CONSULTED AND IT WAS DETERMINED ON (B)(4) 2012 THAT THE EVENT WAS REPORTABLE TO FDA. THIS EVENT IS SIMILAR TO OTHER EVENTS PREVIOUSLY REPORTED BY TRANSENTERIX AND THE INVESTIGATION INTO THE ROOT CAUSE OF THE EVENT IS BASED ON THE INVESTIGATION OF THOSE PRIOR EVENTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE JAW FROM A FLEXIBLE GRASPER BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN JAW FROM THE ABDOMINAL SPACE. NO INJURY OR IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FLEXIBLE GRASPER GCJ, LAPAROSCOPIC INSTRUMENT/ACCESSORY GCJ TRANSENTERIX INC. 9000026 DC363112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK