BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17067918 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15909
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    November 1, 2021
    Report Date
    December 20, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115930
    PMA / PMN Number
    K180351
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT "DURING A PROCEDURE, INSTRUMENT WASN'T WORKING, AND CUSTOMER FOUND IRON TIP WHICH COVERED CABLES WAS POPPED OUT AND TIP WASN'T OPENED". THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE STICKING OUT FROM THE DISTAL END. A LOOP OF WIRE IS STICKING OUT SUCH THAT THE WIRE PROTRUDES ABOVE THE OUTER SURFACE OF THE GRIP TIPS ASSEMBLY. THIS FAILURE CAN AFFECT THE OPENING OF THE GRIP TIPS. THE INSTRUMENT FAILED AN ELECTRICAL CONTINUITY TEST. ADDITIONALLY, FA FOUND THE INSTRUMENT TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRES INSULATION AT THE DISTAL END. THE CONDUCTOR WIRE WAS EXPOSED AS A RESULT. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. NO SIGNS OF THERMAL DAMAGE OBSERVED. THE INSTRUMENT ALSO WAS FOUND TO HAVE MECHANICAL INDENTATION DAMAGE TO THE DISTAL PULLEY. NO MATERIAL MISSING. THE DAMAGED PULLEY IS LOCATED NEAR THE DEFECTIVE CONDUCTOR WIRE. THE INSTRUMENT WAS FOUND TO HAVE MECHANICAL INDENTATION/BURRS TO THE GRIP TIPS. NO MATERIAL MISSING. THE GRIP TIP DAMAGE IS LOCATED NEAR THE DEFECTIVE CONDUCTOR WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE FORCE BIPOLAR DID NOT MOVE. THE CUSTOMER REMOVED THE INSTRUMENT TO CHECK AND FOUND THAT THE METAL TIP COVERING THE WIRE CAME OUT AND DID NOT OPEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH ANOTHER INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS BEING USED FOR DISSECTING THE TISSUE, THEN THE METAL COVER OF THE SILVER WIRE WAS DISLODGED. NO LOSS OF CAUTERY OR DAMAGE NOTICED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO SIGNS OF THERMAL DAMAGE OBSERVED. NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT, AND THERE WAS NO REPORTED PATIENT INJURY. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) WAS PROVIDED FOR ISI REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION. UPON FURTHER FOLLOW UP, THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS NOT GRASPING A TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188520 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 470405-06 N10201019 0046 00886874115930

    Patients

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