BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 5632698 · Received May 4, 2016

    Report

    Report Number
    2955842-2016-00307
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    April 7, 2016
    Report Date
    April 8, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF FRAYED WIRE AND INSULATOR (RESIN) DAMAGE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN YAW PULLEY. THE YAW PULLEY WAS MISSING A 0.096 X 0.159 PIECE OPPOSITE OF THE CONDUCTOR BREAK. THIS ALLOWED THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION IN THE YAW. BROKEN DAMAGE IS DUE TO MISHANDLING / MISUSE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PIECE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT IS MISSING AND POTENTIALLY BROKE OFF INTO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE DAY AFTER A DA VINCI ASSISTED PROSTATECTOMY PROCEDURE, THE CUSTOMER IDENTIFIED A FRAYED WIRE AND INSULATOR RESIN DAMAGE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE SURGEON STATED IT WAS HIGHLY POSSIBLE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN BUT THE RESULTS WERE INDETERMINATE. ON 04/26/2016, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) FOR ADDITIONAL INFORMATION. THE CSR INDICATED NO VIDEO OF THE PROCEDURE WAS AVAILABLE TO REVIEW AND THE PATIENT HAS NOT RETURNED EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286902 FENESTRATED BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-10 N10150907 139

    Patients

    Seq Age Sex Outcome Treatment
    1