BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3031614 · Received April 2, 2013

    Report

    Report Number
    2955842-2013-01077
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE ONE GRIP WAS BENT, CAUSING SIDE-TO-SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .127 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. THE ELECTRICAL CONTINUITY TESTING PASSED. ENGINEERING ALSO FOUND A FRAYED AND LOOSE PITCH CABLE AT THE DISTAL CLEVIS HUB. NO OTHER CABLE DAMAGE WAS FOUND. ENGINEERING ALSO FOUND SCRATCHES ON THE DISTAL PULLEY. THERE WERE VARIOUS SCRATCH MARKS ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. 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 SI SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIPS DID NOT ALIGN. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134716 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120927 177

    Patients

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