BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP COVER ASSEMBLY

    MDR report key: 1386930 · Received May 14, 2009

    Report

    Report Number
    1386930
    Event Type
    Malfunction
    Date Received
    May 14, 2009
    Date of Event
    May 11, 2009
    Report Date
    May 13, 2009
    Manufacturer
    DISTRIBUTED BY INTUITIVE SURGICAL, MADE BY MICROTEC MED
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2009, A PT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE. DURING THE PROCEDURE, A HOT SHEAR INSTRUMENT TIP ARCED TO THE BOWEL. THE PHYSICIAN EXAMINED THE PATIENT AND DID NOT FEEL THERE WAS ANY PATIENT INJURY AT THAT TIME. THE CASE PROCEEDED AND WAS COMPLETED WITHOUT FURTHER EVENT. THE ROBOTIC INSTRUMENT WAS CHANGED OUT AND FOUND THAT THE ONE TIME USE PLASTIC PROTECTIVE TIP HAD A HOLE. IT IS UNK IF THE PATIENT WILL HAVE ANY UNDESIRED EFFECTS FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIP COVER ASSEMBLY PLASTIC PROTECTIVE TIP NAY DISTRIBUTED BY INTUITIVE SURGICAL, MADE BY MICROTEC MED 400180-05 C8283

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR