BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOWEL GRASPER INSTRUMENT

    MDR report key: 3140314 · Received May 31, 2013

    Report

    Report Number
    2955842-2013-01939
    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 MAIN TUBE INSULATION EXHIBITED DAMAGE FROM THE DISTAL END UNTIL APPROXIMATELY 4.5 INCHES BELOW. THE INSULATION WAS FOUND WITH SEVERAL GOUGE MARKS WITHIN THAT AREA. THE MARKS WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. THE MAIN TUBE ALSO EXHIBITED A COUPLE OF DIFFERENT DAMAGED SECTIONS WITH TUBE INSULATION REMOVED. THE MAIN TUBE ALSO APPEARED WITH DISCOLORATION MARKS WITH NO MATERIAL LOSS THROUGHOUT THE ENTIRE MAIN TUBE. 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 DURING A DA VINCI S SIGMOID COLECTOMY PROCEDURE, THE INSULATION ON THE BOWEL GRASPER INSTRUMENT SCRAPPED OFF. NO MISSING OR FALLEN PIECES WERE REPORTED. REPORTEDLY, THE PLANNED SURGICAL PROCEDURE WAS COMPLETED USING OPEN SURGICAL TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242072 BOWEL GRASPER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-04 S10121010 933

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other DA VINCI S SURG SYS, INSTRUMENTS AND ACCESSORIES