BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 2265386 · Received March 4, 2011

    Report

    Report Number
    3007593944-2011-00002
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K090902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TETHER WIRE HOLDING THE NOSE CONE (CAP TO THE INTRODUCER SHEATH) BROKE. THE NOSE CONE AND PART OF THE TETHER WIRE DROPPED INTO THE SURGICAL SPACE AND WERE RETRIEVED BY THE SURGEON. INVESTIGATION IS NOT COMPLETE BUT IT APPEARS THAT THE WIRE MAY HAVE BEEN CUT DURING THE PROCEDURE, DAMAGING THE WIRE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK