BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17558346 · Received August 16, 2023

    Report

    Report Number
    2955842-2023-17774
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 18, 2023
    Report Date
    July 18, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE IMPRECISE MOTION FAILURE. THIS INSTRUMENT'S GRIP TIP WAS NOT MOVING INTUITIVELY. THE INSTRUMENT TIP DID NOT MOVE INTUITIVELY AT THE PITCH ORIENTATION. THE INSTRUMENT EXHIBITED IMPRECISE MOTION WHICH CONFIRMED THE REPORTED COMPLAINT JOINT BEING OUT OF CONTROL. IN ADDITION, WITH THE PRIMARY REPORTED COMPLAINT, THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST AND SUCCESSFULLY PERFORMED ENERGY DELIVERY TEST ON AN IN-HOUSE SYSTEM. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A LOOSE PITCH CABLE. FURTHER INVESTIGATION FOUND THAT THE INSTRUMENT HAD A LOOSE PITCH CABLE ON THE DISTAL END. AS A RESULT, THE INSTRUMENT EXHIBITED AN IMPRECISE MOTION TEST ON AN IN-HOUSE SYSTEM. NO CRACKED CLAMPING PULLEY, NO BROKEN INPUT DISK, AND NO BROKEN CABLE WERE FOUND DURING VISUAL INSPECTION. A CRACKED CLAMPING PULLEY AND/OR INPUT SHAFT CAN CAUSE THE CABLE TO BECOME DISLODGED AT THE PROXIMAL END. WHEN CLAMPING PULLEY AND/OR INPUT SHAFT IS CRACKED, THE CABLE CAN DISLODGE AS THE INPUT COULD "SLIP" WITH RESPECT TO ITS INTERNAL SHAFT CAUSING THE LOSS OF CABLE TENSION. A CRACKED CLAMPING PULLEY AND/OR INPUT SHAFT CAN BE CAUSED BY IMPROPER CLEANING OR STERILIZATION TECHNIQUES USED DURING REPROCESSING. A DISLODGED CABLE AT THE PROXIMAL END CAN THEN RESULT IN THE CABLE BECOMING DERAILED OR LOOSE AT THE DISTAL END WHICH MAY LEAD TO NON-INTUITIVE MOTION. THE MARYLAND BIPOLAR FORCEPS WAS ALSO FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE'S INSULATION. THE CONDUCTOR WIRE'S INSULATION WAS FOUND PINCHED AT THE YAW PULLEY DISTAL END WITH NO EXPOSED INTERNAL WIRE. THERE WAS NO SIGN OF THERMAL DAMAGE OBSERVED AND NO MISSING PIECE OF THE INSULATION WIRE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. ENERGY DELIVERY WAS PERFORMED, AND NO ISSUE WAS FOUND. THE INSTRUMENT WAS FOUND TO HAVE SCRATCH MARKS/ABRASIONS ON THE EDGE OF THE BIPOLAR YAW PULLEY. THE SCRATCH MARK/ABRASION WAS FOUND NEAR WITH THE CONDUCTOR WIRE INSULATION DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. REVIEW OF THE PROVIDED IMAGE BY A REGULATORY POST MARKET SURVEILLANCE ANALYST SHOWS NO VISIBLE DAMAGE TO THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS WAS FOUND TO HAVE A JOINT OUT OF CONTROL AND NO ENERGY. THE PROCEDURE WAS COMPLETED USING A BACKUP MARYLAND BIPOLAR FORCEPS WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON'S HEAD WAS INSIDE OF THE HIGH-RESOLUTION STEREO VIEWER WHEN THE ISSUE OCCURRED. THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS WHEN THE ISSUE OCCURRED. THERE WAS NO FAILURE RELATED TO THE INABILITY TO MOVE THE INSTRUMENT. THE MOVEMENTS DID NOT SCALE APPROPRIATELY TO THE INSTRUMENT. THE INSTRUMENT DID NOT MOVE IN THE INTENDED DIRECTION. THE TIMING WAS APPROPRIATE BUT DID NOT MATCH THE SURGEON'S EXPECTATIONS. THERE WAS NO SHAKINESS OBSERVE, NO INSTRUMENT TO INSTRUMENT OR SYSTEM ARM TO ARM INTERFERENCE. THERE WERE NO EXTERNAL COLLISIONS. THE ISSUE WAS PERSISTENT AND OCCURRED WHEN THE OPERATION JUST STARTED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO ABNORMALITY OBSERVED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490482 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-17 K10221204 0202 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES