BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15296646 · Received August 25, 2022

    Report

    Report Number
    2955842-2022-13655
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    April 14, 2022
    Report Date
    July 26, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    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

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS COULD NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS RETURNED WITH A REPORTED COMPLAINT THAT DOES NOT AFFECT FUNCTIONALITY. NO DAMAGE WAS OBSERVED ON THE INSTRUMENT. A REVIEW OF THE INSTRUMENT LOG SHOWED THE INSTRUMENT HAD NO LIVES REMAINING AND EXPIRED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS FOUND TO HAVE 0 LIVES REMAINING. THE LIFE INDICATOR ROTATED TO RED AS INTENDED. THERE WAS NO PROBLEM DETECTED. THERE WAS AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THE BROKEN PITCH CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE ROOT CAUSE OF THIS FAILURE WAS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE INSTRUMENT LOG SHOWED THE PERMANENT CAUTERY HOOK INSTRUMENT (PART# 470183-14 / LOT# N10210202-0063) WAS LAST USED ON (B)(6) 2022 .DURING A PROCEDURE WITH SYSTEM (B)(4). THE PERMANENT CAUTERY HOOK INSTRUMENT HAD 0 USES REMAINING. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS INVESTIGATIONS CONFIRMED A BROKEN PITCH CABLE ON THE PERMANENT CAUTERY HOOK INSTRUMENT WITH MISSING MATERIAL. THE MISSING PIECE COULD FALL INSIDE THE PATIENT DURING THE SURGICAL PROCEDURE. WHILE THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT, AND THE CUSTOMER HAD REPORTED THAT NO FRAGMENT FELL INSIDE THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS UNINTENDED FRAGMENT(S) FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER DISCOVERED THAT THE PERMANENT CAUTERY HOOK INSTRUMENT LIFE INDICATOR TURNED RED. THE CUSTOMER REPLACED THE PERMANENT CAUTERY HOOK INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT NO FRAGMENTS FELL INSIDE THE PATIENT DURING THE PROCEDURE BECAUSE THE BREAKAGE OCCURRED OUTSIDE OF THE PATIENT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318189 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N10210202 0063 00886874112311

    Patients

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