BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 2066183 · Received March 29, 2011

    Report

    Report Number
    3007593944-2011-00003
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 25, 2011
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K102839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AT THE START OF A LAPAROSCOPIC PROCEDURE, A RIVET FELL INTO THE ABDOMINAL SPACE. INVESTIGATION OF THE RETURNED PRODUCT FOUND THAT THE RIVET DID NOT BREAK; RATHER IT WAS IMPROPERLY INSTALLED. NO INJURY OR IMPACT TO PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - SINGLE PORT SURGICAL DEVICE GCJ TRANSENTERIX, INC. 9000020 TRX327201002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK