BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22102947 · Received May 29, 2025

    Report

    Report Number
    2955842-2025-22673
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 12, 2025
    Report Date
    May 12, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS EVENT IS NON-REPORTABLE. THE CUSTOMER ALLEGED THE CABLE WAS NOT FULLY BROKEN AND THOUGH THERE WERE INSULATION DAMAGE, WIRE WAS NOT EXPOSED. CUSTOMER CONFIRMED NO FRAGMENTS FELL INTO THE PATIENT. CABLE FAILURE CAN BE CAUSED BY A FEW DIFFERENT THINGS, INCLUDING EXTERNAL COLLISIONS OR OTHER SOURCES OF DAMAGE DURING USE OR DURING REPROCESSING. AN INSTRUMENT WITH A LOOSE CABLE WILL BE DETECTED BY A SURGEON AS WRIST MOVEMENT AT THE DISTAL END OF THE INSTRUMENT WILL NOT BE PRECISE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE TALKED TO THE SITE AND FOUND THAT THEY INSTALLED ANOTHER INSTRUMENT, AND IT WORKED PROPERLY. THE SYSTEM WAS VERIFIED AND READY FOR USE.

    Additional Manufacturer Narrative · 0

    CUSTOMER ALSO RECEIVED A FENESTRATED BIPOLAR FORCEPS. THE BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A SEVERELY BENT GRIP, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A 0.056¿ OFFSET AT THE TIPS. COMMON CAUSES OF THE FAILURE MODE BENT-SEVERELY INSTRUMENT GRIPS -TIPS ARE ATTRIBUTED TO DAMAGE DURING EITHER USE OR REPROCESSING, AS SEVERE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO ACCIDENTAL DROPS, INCORRECT INSTRUMENT TRAY OR SINK SIZES FOR REPROCESSING, OR OVERLOADING THE TIPS BY APPLYING EXCESSIVE FORCE ON THE JAWS. THE BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE DISLODGED AND STICKING OUT FROM THE DISTAL CLEVIS. A LOOP OF WIRE IS STICKING OUT SUCH THAT THE WIRE PROTRUDES ABOVE THE OUTER SURFACE OF THE MAIN TUBE. THE WIRE INSULATION WAS NOT DAMAGED, AND THE INSTRUMENT PASS AN ELECTRICAL CONTINUITY TEST. COMMON CAUSES OF DISLODGED INSTRUMENT CONDUCTOR WIRE - BIPOLAR ARE ATTRIBUTED TO DAMAGE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THE INSTRUMENT TIPS WON'T CLOSE ALL THE WAY. THE CALLER STATED THE FENESTRATED BIPOLAR INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) #4, THE TIPS WEREN'T CLOSING ALL THE WAY. (WILL BE ADDRESSED ON A SEPARATE PR) CALLER STATED THEY HAVE ALSO USED 2 MARYLAND BIPOLAR INSTRUMENTS ON USM 2 AND THE TIPS OF THE INSTRUMENTS WEREN'T CLOSING ALL THE WAY. (WILL BE ADDRESSED IN SEPARATE PR). TSE RECOMMENDED THE CUSTOMER RESEATED THE INSTRUMENT AND STERILE ADAPTER (SA). CALLER RESEATED THE INSTRUMENT AND SA AND GOT A MESSAGE ENGAGEMENT FAILURE. CUSTOMER TRIED TO RESEAT THE INSTRUMENT AND SA AND MOVED THE INSTRUMENT TO USM #1 AND GOT AN ENGAGEMENT FAILURE. CUSTOMER TRIED TO USE A PROGRASP INSTRUMENT ON USM #1 AND IT ENGAGED. CALLER HAD ENGAGEMENT ISSUES ON USM #1 BUT THEN TRIED A NEEDLE DRIVER AND IT DID ENGAGE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC RIGHT PARTIAL NEPHRECTOMY WAS THE PROCEDURE THAT WENT FROM 7:30 AM - 1:25 PM. MARYLAND #1: PART# 471172, LOT# K10240926 0176, MARYLAND #2 -: PART# 471172, LOT # K11241121 0382, FENESTRATED BIPOLAR: PART# 471205, LOT# K15250403 0409. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE DOCTOR WAS TRYING TO CAUTERIZE THE TISSUE WHEN THE ISSUE OCCURRED. THE GRIPS DID NOT CLOSE AND THERE WAS ONE CABLE VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT AND IT WAS THE ONE THAT CONTROLS THE OPENING/CLOSING OF THE JAWS. THE COLOR WAS BLACK AND IT WAS LOOSE. THERE WAS NO FULL CABLE BREAKAGE AND NO EXPOSED WIRE DUE TO DAMAGED INSULATION. NO LOSS OF CAUTERY ASSOCIATED WITH BROKEN OR LOOSE CABLE. NO ARCING OBSERVED OR NO THERMAL DAMAGE. NO FRAGMENTS FELL INSIDE THE PATIENT. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626389 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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