BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 22127727 · Received June 2, 2025

    Report

    Report Number
    2955842-2025-23427
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 13, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA HAD BEEN ISSUED REQUESTING TO HAVE THE ISI DEVICE RETURNED; HOWEVER, ISI DID NOT RECEIVE THE RMA TO CONFIRM/IDENTIFY THE FAILURE MODE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER-REPORTED COMPLAINT REGARDING THE BROKEN INSTRUMENT. THE PRIMARY FAILURE OF A BROKEN MOLDED INSULATOR ON THE UPPER JAW WAS DETERMINED TO BE RELATED TO THE REPORTED ISSUE. THE BROKEN MOLDED INSULATOR MEASURED APPROXIMATELY 4.35 MM X 9.80 MM AND WAS NOT RETURNED WITH THE INSTRUMENT. ADDITIONALLY, THE GRIP TIP FROM THE UPPER MOLDED INSULATOR WAS ALSO NOT RETURNED. THE GRIP BASE ASSOCIATED WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT. ADDITIONALLY, THE INSTRUMENT HAD A DETACHED FRAGMENT, WHICH INCLUDED THE BROKEN MOLDED INSULATOR AND GRIP. THE GRIP TIP FROM THE DETACHED FRAGMENT WAS NOT RETURNED. A BROKEN CONDUCTOR WIRE WAS OBSERVED AT THE GRIP BASE, WHICH IS BELIEVED TO HAVE RESULTED FROM THE BREAKAGE OF THE MOLDED INSULATOR. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF BROKEN MOLDED INSULATOR IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL. THE PROBABLE ROOT CAUSE OF DETACHED FRAGMENTS IS ATTRIBUTED TO BROKEN MOLDED INSULATOR AND GRIP. THE PROBABLE ROOT CAUSE OF BROKEN CONDUCTOR WIRE IS ATTRIBUTED TO BROKEN MOLDED INSULATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE DA VINCI ASSISTED SURGICAL PROCEDURE; MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS DEFECTIVE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INSTRUMENT BROKE WHILE GRASPING TISSUE, THE ISSUE INVOLVES LIMITED OR IMPRECISE MOTION. THE INSTRUMENT WAS IDENTIFIED WITH A BROKEN CONDUCTOR WIRE. TWO BROKEN AREAS WHERE THE TIP IS ATTACHED. ONE IS BROKEN ON THE SHAFT WHERE THE INSTRUMENT WAS WELDED TOGETHER.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619450 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-62 K10240418 0016 00886874114322

    Patients

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