BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3066770 · Received April 18, 2013

    Report

    Report Number
    2955842-2013-01310
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT HAD DAMAGE ON THE DISTAL END, A BROKEN PITCH CABLE, NOT FRAYED. THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINED THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ENGINEERING ALSO FOUND SEVERAL SCRATCH MARKS ON THE DISTAL END OF THE MAIN TUBE EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE THE PRECISE BIPOLAR FORCEPS INSTRUMENT WAS NOTED TO HAVE FRAYED CABLES AT THE DISTAL END. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167611 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10120702 450

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SYSTEM, ESU, INSTRUMENTS & ACCESSORIES