BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3970929 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04639
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    March 31, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. NO OTHER DAMAGE OR WEAR MARKS WERE OBSERVED ON THE CLEVIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STUCK OUT AT THE WRIST. 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. THERE WERE INDENTATIONS AT THE EDGE OF THE INSTRUMENT'S DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. IT WAS CONCLUDED THAT THE INDENTATION DAMAGE FOUND TO THE DISTAL PULLEY WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGED CABLES AND/OR TUBE ABRASIONS WITH MATERIAL REMOVED, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, A BROKEN CABLE WAS IDENTIFIED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE INSTRUMENT WAS NOT MOVING PROPERLY. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE 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
    448273 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10130925 309

    Patients

    Seq Age Sex Outcome Treatment
    1