BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3882374 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03764
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND BOTH INSTRUMENT GRIPS WERE BENT OUTWARD CREATING THE MISALIGNMENT THEREFORE PREVENTING THE GRIPS FROM CLOSING TO AND GENERATING ENERGY. THERE WAS A .122 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. ELECTRICAL CONTINUITY TESTING WAS PERFORMED AND PASSED. FAILURE ANALYSIS CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING / MISUSE. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING UNREPORTED DAMAGES TO THE INSTRUMENT: THE PITCH CABLE WAS FRAYED AT THE DISTAL IDLER. NO DAMAGE WAS FOUND ON THE PULLEY AND CLEVIS. AN ADDITIONAL OBSERVATION NOT REPORTED WERE VISIBLE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE AND TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PELVIC LYMPHADENECTOMY PROCEDURE, THE FENESTRATRED BIPOLAR FORCEPS INSTRUMENT WAS NOT ENERGIZED. BY CONFIRMING THE TIP OF THE INSTRUMENT, THE JAWS WERE NOT ENGAGED. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357183 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10131203 051

    Patients

    Seq Age Sex Outcome Treatment
    1