BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3882266 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03755
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. THE PITCH CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE. AN ADDITIONAL OBSERVATION NOT REPORTED WERE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. NO OTHER DAMAGE WAS FOUND. AN ADDITIONAL OBSERVATION NOT REPORTED WAS THE BIPOLAR PIN WAS BENT UPWARDS TOWARD THE TOP PIN. THE CHASSIS FEATURE THAT ACTS AS A HARDSTOP FOR THE PINS WAS NOT BROKEN. ELECTRICAL CONTINUITY TESTING WAS PERFORMED AND PASSED. FAILURE ANALYSIS CONCLUDED THE BENT PIN WAS LIKELY DUE TO MISHANDLING / MISUSE. 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 FRAYED 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 IN CENTRAL PROCESSING, THE DISTAL WIRE WAS FRAYED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358157 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 N10140106 729

    Patients

    Seq Age Sex Outcome Treatment
    1