BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3923709 · Received July 9, 2014

    Report

    Report Number
    2955842-2014-04189
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 25, 2014
    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

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S PITCH CABLE WAS BROKEN. THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINED THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S GRIP CABLE WAS FRAYED. THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE INSTRUMENT'S DISTAL PULLEY HAD MECHANICAL INDENTATIONS AND BURRS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THAT THE MECHANICAL INDENTATION AND BURR DAMAGE WAS LIKELY DUE TO MISHANDLIN G/MISUSE. THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. 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 IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE, FRAYED CABLE AND DAMAGE TO THE MAIN TUBE FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT A BROKEN WIRE WAS OBSERVED ON THE PROGRASP FORCEPS INSTRUMENT. 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
    399634 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M10140130 746

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR