BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3767150 · Received April 23, 2014

    Report

    Report Number
    2955842-2014-02470
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 1, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM A NURSE AT THE SITE. THE NURSE INDICATED THAT ACCORDING TO THE SURGEON'S OPERATIVE NOTE, THE DA VINCI MYOMECTOMY PROCEDURE WAS CONVERTED TO A LAPAROTOMY DUE TO THE PATIENT'S ANATOMY AND TO CONTROL BLEEDING. IT IS UNCLEAR IF THE BROKEN SHAFT ISSUE WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS FOUND DURING CENTRAL PROCESSING OR INTRA-OPERATIVELY. THE LAPAROTOMY PROCEDURE WAS COMPLETED SUCCESSFULLY. THE NURSE DID NOT KNOW THE PATIENT'S CURRENT STATUS.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENTS TUBE EXTENSION WAS BROKEN. THE TUBE EXTENSION WAS BROKEN AND MISSING A .207 X .213 PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM TUBE EXTENSION. THE TUBE EXTENSION WAS FRACTURED NEXT TO ONE OF THE KEYS THAT MATED WITH THE PROXIMAL CLEVIS. FAILURE ANALYSIS CONCLUDED THAT THE TUBE EXTENSION DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENTS TUBE EXTENSION PADDING WAS REMOVED. THE PAD PRINTING WAS REMOVED AT VARIOUS AREAS ON TUBE EXTENSION, ONE OF THEM MEASURING APPROXIMATELY .086 X .189. FAILURE ANALYSIS INVESTIGATION CONCLUDED THAT THE PAD PRINTING REMOVAL DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENTS MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .142 - .179 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, IT WAS NOTED THAT THE SHAFT ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS BROKEN. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246531 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10131206 753

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR