BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3961090 · Received July 28, 2014

    Report

    Report Number
    2955842-2014-04561
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S GRIP TIPS WERE BENT. ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .360 OFFSET AT THE TIPS. THE BENT GRIP DID NOT EXHIBIT SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, HOWEVER LIKELY CAUSE OF BENDING REMAINS OVERLOADING AT THE TIP. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. FAILURE ANALYSIS CONCLUDED THAT THE BENT DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S BIPOLAR YAW PULLEY WAS BROKEN. THERE WAS A SMALL PIECE BROKEN OFF OF PULLEY, LOCATED NEXT TO GRIP. THE MISSING PIECE MEASURED APPROXIMATELY .046 X .063. FAILURE ANALYSIS CONCLUDED THAT THE BROKEN DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. THE INSTRUMENT'S CLAMPING PULLEY WAS CORRODED AND CONTAMINATED. THE INSTRUMENT'S HOUSING WAS OPENED FOR A THOROUGH INSPECTION AND FOUND THE CLAMPING PULLEY HAD PITTING. FAILURE ANALYSIS CONCLUDED THAT THE CORRODED AND CONTAMINATED DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. NO OTHER DAMAGE WAS FOUND. 80 - 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 REPROCESSING INSTRUCTIONS UNDER CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION SECTION SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN YAW PULLEY IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING THAT THE TIPS OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT DID NOT MATCH UP. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439178 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10120913 511

    Patients

    Seq Age Sex Outcome Treatment
    1