BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3950022 · Received July 22, 2014

    Report

    Report Number
    2955842-2014-04471
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 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 FRAYED. THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S PITCH CABLE WAS LOOSE. THE PITCH CABLE WAS FOUND LOOSE AT THE DISTAL CLEVIS HUB. BOTH CABLE CRIMPS REMAINED IN THE CLEVIS AND FRAYED WAS FOUND ON THE CABLE. UPON HOUSING REMOVAL, A FRAYED PITCH CABLE WAS FOUND DERAILED AT THE CLAMPING PULLEY, BUT NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. THE INSTRUMENT'S CLAMPING PULLEY WAS CORRODED AND CONTAMINATED. CORROSION WAS ALSO FOUND ON THE CLAMPING PULLEY WHERE THE CABLE RAILS WERE LOCATED. FAILURE ANALYSIS CONCLUDED THAT THE CORRODED AND CONTAMINATED DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF 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 REPROCESSING INSTRUCTIONS UNDER CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION SECTION SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; 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 HYSTERECTOMY SURGICAL PROCEDURE THAT A BROKEN CABLE 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
    428606 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M11140220 164

    Patients

    Seq Age Sex Outcome Treatment
    1