BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3962201 · Received July 28, 2014

    Report

    Report Number
    2955842-2014-04578
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    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 THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. AN ADDITIONAL OBSERVATION NOT REPORTED WAS AN INDENTATION AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING / MISUSE. NO OTHER DAMAGE WAS FOUND. 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 BROKEN CABLE 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 DURING A DA VINCI SURGICAL PROCEDURE, THERE WERE WIRES HANGING OUT OF THE PK DISSECTING FORCEPS INSTRUMENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439845 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-05 N10140324 589

    Patients

    Seq Age Sex Outcome Treatment
    1