BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL CLIP APPLIER INSTRUMENT

    MDR report key: 3932477 · Received July 14, 2014

    Report

    Report Number
    2955842-2014-04258
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE TIPS OF THE INSTRUMENTS' GRIPS WERE BROKEN. BOTH OF THE CLIP APPLIER GRIPS WERE BROKEN ROUGHLY AT THE MIDPOINT. THE BROKEN PIECES MEASURED APPROXIMATELY 0.139 X 0.050 AND 0.027 X 0.050 AND WERE NOT RETURNED WITH THE INSTRUMENT. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING UNREPORTED DAMAGES: THE PITCH CABLE WAS FRAYED AT THE DISTAL. NO DAMAGE WAS FOUND AT THE CLEVIS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY. FAILURE ANALYSIS CONCLUDED THAT THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING. 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 REPORTABLE EVENT; HOWEVER, THE BROKEN GRIPS AND THE BROKEN CABLE FOUND DURING FAILURE ANALYSIS 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 SURGICAL PROCEDURE, THE SMALL CLIP APPLIER INSTRUMENTS' TIP DID NOT HOLD THE CLIP. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410850 SMALL CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420003-06 S10100720 900

    Patients

    Seq Age Sex Outcome Treatment
    1