BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER SURGICAL PLATFORM

    MDR report key: 2372102 · Received December 9, 2011

    Report

    Report Number
    3007593944-2011-00010
    Event Type
    Injury
    Date Received
    December 9, 2011
    Date of Event
    November 4, 2011
    Report Date
    December 9, 2011
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    OTJ
    PMA / PMN Number
    K102839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELED INSTRUCTIONS FOR THE SPIDER DEVICE CLEARLY INDICATE TO REMOVE DEVICE BEFORE REMOVING INSUFFLATION WHICH IS ALSO STANDARD LAPAROSCOPIC TECHNIQUE. LACK OF PROPER INSUFFLATION WAS THE PRIMARY CONTRIBUTING FACTOR IN THIS EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE PHYSICIAN WHO REPORTED THE INCIDENT, THE PT WAS NOT GIVEN ENOUGH ANESTHESIA AND THE ABDOMEN BECAME TIGHT, PUSHING THE BOWEL FORWARD. THIS OCCURRED AT THE END OF THE LAPAROSCOPIC SURGICAL PROCEDURE WHEN THE SURGEON WAS JUST STARTING TO WITHDRAW THE SPIDER DEVICE. BECAUSE THE ABDOMEN WAS THEN LOW, THE TETHER WIRE DRAGGED AGAINST THE BOWEL CAUSING A SMALL TEAR IN THE BOWEL. THE SURGEON REPAIRED THE INJURY BY STITCHING THE BOWEL. THE SURGEON DID NOT ATTRIBUTE THE INCIDENT TO THE MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER SURGICAL PLATFORM OTJ, LAPAROSCOPIC SINGLE PORT ACCESS OTJ TRANSENTERIX INC. 9000020 G2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention