BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3241636 · Received July 22, 2013

    Report

    Report Number
    2955842-2013-02684
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K072627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THAT THE GRIPS WERE BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A 0.020 OFFSET AT THE TIPS. THE BENT GRIP HAD A SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES WERE 0.070 - 0.115 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. EVIDENCE NOT CONCLUSIVE BUT MAIN TUBE DAMAGE IS LIKELY DUE TO MISHANDLING. THE INSTRUMENTS & ACCESSORIES 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 REPORTABLE EVENT; HOWEVER, THE MAIN TUBE DAMAGE FOUND DURING FAILURE ANALYSIS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED A PK DISSECTING FORCEPS INSTRUMENT WITH BENT TIPS. NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340446 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10121106 162

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU