BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 16928217 · Received May 13, 2023

    Report

    Report Number
    2955842-2023-13553
    Event Type
    Injury
    Date Received
    May 13, 2023
    Date of Event
    August 11, 2021
    Report Date
    August 17, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE REPORTED PROBLEM. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN GRIP TIPS TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY .221" X .57 WAS FOUND TO BE BROKEN OFF THE YAW PULLEY. THE BROKEN PIECE WAS NOT RETURNED. THE ROOT CAUSE OF THE BROKEN INSTRUMENT GRIPS TIPS IS TYPICALLY ATTRIBUTED TO MISHANDLING / MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. THIS COMPLAINT IS BEING RECLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO OTHER REPORTED PATIENT INJURY. WHILE THERE WAS NO OTHER REPORT OF HARM OR INJURY TO THE PATIENT, SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE FRAGMENT(S). ADDITIONALLY, THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS, WHICH CONFIRMED THE COMPONENT THAT BROKE/HAD MATERIAL DETACHED/SEPARATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT JAW SNAPPED OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS REMOVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED INJURY. THE CADIERE FORCEPS IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. SURGICAL ASSISTANT REMOVED SINGLE FRAGMENT VIA LAPAROSCOPIC GRASPER UNDER VISION. YES ALL RETRIEVED, SINGLE PIECE WAS PUSHED AGAINST BREAKING POINT AND NO SEGMENTS WERE MISSING; CLEAN BREAK. REPORTEDLY, NO INTRAOPERATIVE COLLISIONS OCCURRED AND THE INSTRUMENT FUNCTIONED NORMALLY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED AND NO POST- OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE CUSTOMER STATED THERE WAS NO INJURY AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS. THE SURGEON STATED NO ISSUES OCCURRED WITH THE INSTRUMENT FUNCTION PRIOR TO THE BREAKAGE AND THINKS THE GRASPING DROP-IN ULTRASOUND PROBE FROM BK MEDICAL AT AN ANGLE MAY HAVE DAMAGED THE INSTRUMENT. THE INSTRUMENT WAS NOT REMOVED BEFORE BREAKAGE AND WAS IN USE WITHOUT ISSUE FOR APPROXIMATELY 30 MINUTES AS THE ULTRASOUND WAS CONDUCTED EARLY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044171 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-07 N10200323 0007 00886874119778

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES