BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FLEXIBLE MONOPOLAR HOOK

    MDR report key: 2773418 · Received September 28, 2012

    Report

    Report Number
    3007593944-2012-00007
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 28, 2012
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE SALES REP INDICATED THAT THE ELECTRICAL CURRENT OF THE MONOPOLAR HOOK APPEARED TO BE CONCENTRATED AT THE HOOK SHAFT RATHER THAN THE TIP OF THE HOOK. THE PHYSICIAN DID NOT REPORT A PROBLEM AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FLEXIBLE MONOPOLAR HOOK LAPAROSCOPIC, GENERAL & PLASTIC SURGERY GCJ TRANSENTERIX INC. 9000031 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK