BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG TIP FORCEPS INSTRUMENT

    MDR report key: 3843926 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03375
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED ON (B)(6) 2014. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT'S DISTAL PULLEYS EXHIBITED SCRATCH MARKS/ABRASIONS. BOTH IDLER PULLEYS EXHIBITED MULTIPLE INDENTATIONS ON THE EDGES. THE CABLES DID NOT EXHIBIT DAMAGE. ADDITIONAL, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE INSTRUMENT'S MAIN TUBE EXHIBITED SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .114 - .157 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A COMPLAINT WITH THE LONG TIP FORCEPS INSTRUMENT BUT DID NOT PROVIDE A DESCRIPTION OF THE EVENT. INTUITIVE SURGICAL, INC. CONTACTED THE USER FACILITY TO OBTAIN MORE INFORMATION ABOUT THE COMPLAINT BUT WAS NOT ABLE TO OBTAIN ANY DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321445 LONG TIP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420048-06 M10110527 235

    Patients

    Seq Age Sex Outcome Treatment
    1