BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 2073635 · Received April 13, 2011

    Report

    Report Number
    3007593944-2011-00004
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K102839
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PT LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON NOTED A THIN STRAND OF PLASTIC EXPOSED/PROTRUDING FROM THE DISTAL TIP OF THE RIGHT INSTRUMENT DELIVERY TUBE OF THE SPIDER INSTRUMENT. THE SURGEON COMPLETED THE PROCEDURE USING THE SPIDER. THE STRAND OF PLASTIC DID NOT DETACH FROM THE DEVICE. NO INJURY OR IMPACT TO THE PT WAS REPORTED. THE DEVICE WITH THE STRAND OF PLASTIC INTACT WAS RETURNED TO TRANSENTERIX FOR INVESTIGATION. THE MATERIAL APPEARS TO BE FROM A TORN LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - SINGLE PORT SURGICAL DEVICE GCJ TRANSENTERIX INC. 9000020 TRX253201003R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK