BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1905192 · Received November 22, 2010

    Report

    Report Number
    2955842-2010-00511
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 8, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND THE INSTRUMENT GRIPS EXHIBIT AN OFFSET OF APPROXIMATELY .015 INCHES AT THE TIPS WHEN CLOSED. THE YAW PULLEY WAS FOUND BROKEN AND CONDUCTOR WIRE IS BROKEN AND DETACHED FROM THE CONNECTION AT THE GRIP. THE YAW PULLEY IS MISSING A .160 INCH BY .060 INCH PIECE OPPOSITE THE CONDUCTOR BREAK ALLOWING THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION IN YAW. PER THE CASE NOTES, THE INSTRUMENT FRAGMENT WAS RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE A PIECE OF THE PK DISSECTING FORCEPS INSTRUMENT FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M1010323 290

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES