BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3525765 · Received December 18, 2013

    Report

    Report Number
    2955842-2013-05791
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 12, 2013
    Report Date
    November 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT TIPS WERE BENT. ONE GRIP IS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE IS A .035 OFFSET AT THE TIPS. THE BENT GRIP DOES NOT EXHIBIT SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT. THIS INDICATES THAT THE LIKELY CAUSE OF BENDING IS OVERLOADING AT THE TIP. THE ELECTRICAL CONTINUITY TEST PASSED. IT WAS CONCLUDED THAT THE DAMAGES TO THE INSTRUMENT'S GRIP TIP WERE LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A FRAYED CABLE. THE PITCH UP CABLE IS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STICK OUT AT THE WRIST. CONDUCTOR WIRES ARE INTACT AND UNDAMAGED. NO OTHER CABLE DAMAGE WAS FOUND. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .023 - .112 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. FAILURE ANALYSIS INVESTIGATION CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S CABLE DAMAGE AND/OR MAIN TUBE DAMAGE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI HYSTERECTOMY PROCEDURE, THE JAWS OF THE PK DISSECTING FORCEPS INSTRUMENT WERE BROKEN. NO MISSING OR FALLEN PIECES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663023 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10130710 283

    Patients

    Seq Age Sex Outcome Treatment
    1