BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3833195 · Received May 27, 2014

    Report

    Report Number
    2955842-2014-03242
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 DISTAL PULLEY HAD SCRATCH MARKS AND ABRASIONS. THERE WERE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, IT WAS NOTED THAT SNAPPED WIRES WERE OBSERVED ON THE PROGRASP FORCEPS INSTRUMENT. 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
    311289 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11131001 742

    Patients

    Seq Age Sex Outcome Treatment
    1