BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOWEL GRASPER INSTRUMENT

    MDR report key: 3140388 · Received May 31, 2013

    Report

    Report Number
    2955842-2013-01937
    Event Type
    Other
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE BLACK TUBE INSULATION WAS DAMAGED AT THE DISTAL END. THE INSULATION WAS GOUGED IN VARIOUS PLACES AND HAD A .324 X.089 1ST PIECE OF INSULATION LIFTED UP, A 2ND PIECE MEASURED APPROXIMATELY 0.231 X 0.115, AND THE LAST PIECE MEASURED APPROXIMATELY 0.306 X 0.092. THE METAL SHAFT WAS EXPOSED AS A RESULT. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. INTUITIVE SURGICAL, INC. HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI S SIGMOID COLECTOMY PROCEDURE, THE INSULATION ON THE BOWEL GRASPER INSTRUMENT WAS NOTED TO HAVE A PUNCTURE. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242172 BOWEL GRASPER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-04 S10120216 261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURG SYS., INSTRUMENTS AND ACCESSORIES