BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3960272 · Received July 28, 2014

    Report

    Report Number
    2955842-2014-04549
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THE INSTRUMENT'S PITCH CABLE TO BE LOOSE AT THE DISTAL CLEVIS HUB. BOTH CABLE CRIMPS REMAINED IN THE CLEVIS. UPON HOUSING REMOVAL, A LOOSE PITCH CABLE WAS FOUND AT THE CLAMPING PULLEY, HOWEVER NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. IN ADDITION, THE INSTRUMENT'S PITCH CABLE WAS ALSO FRAYED AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES: THE INSTRUMENT'S CLAMPING PULLEY WAS CORRODED/CONTAMINATED. THE CORRODED CLAMPING PULLEY WAS INSIDE THE HOUSING AROUND THE CABLE RAIL AREA AND AN "ORANGEY" LIKE COLOR WAS OBSERVED ON THE BEARINGS. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE MAY BE DUE TO IMPROPER CLEANING. THE INSTRUMENT'S DISTAL PULLEY HAD MECHANICAL INDENTATIONS/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 INDENTATIONS/BURRS DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. IN ADDITION, THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WHICH EXHIBITED LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND. 80 - 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 INSTRUMENTS AND ACCESSORIES USER MANUAL 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 FRAYED CABLE AND VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL 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 SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WIRES WERE REALLY LOOSE OR BROKEN IN THE SHAFT OF THE PROGRASP FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437514 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10131125 196

    Patients

    Seq Age Sex Outcome Treatment
    1