BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 15375435 · Received September 7, 2022

    Report

    Report Number
    2955842-2022-13892
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    May 17, 2022
    Report Date
    August 10, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111338
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CADIERE FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE AT THE DISTAL END OF THE INSTRUMENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. ROOT CAUSE OF A BROKEN PITCH CABLE IS A COMPONENT FAILURE. PITCH CABLE BREAKAGE OCCURS WHEN TENSILE LOAD EXCEEDS THE ULTIMATE STRENGTH OF THE MATERIAL. THE PITCH CABLE CONSTRUCTION IS DESIGNED TO OPTIMIZE LOAD AND FATIGUE (CYCLING) CHARACTERISTICS. VARIATION IN CUSTOMER USE CONDITIONS, PROCEDURE TYPE, PATIENT ANATOMY, PRODUCT HANDLING, INSTRUMENT TIP LENGTHS, GRIP TORQUE, AND MANUFACTURING TOLERANCES ARE A FEW VARIABLES WHICH CAN INFLUENCE PITCH CABLE FAILURE.A REVIEW OF THE INSTRUMENT LOG FOR THE CADIERE FORCEPS INSTRUMENT (PN# 420049-9 LOT# N10171024-280) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON 05/17/2022 ON SYSTEM SH2200 FOR APPROXIMATELY 1 HOUR 44 MINUTES. THE ALLEGED EVENT OCCURRED ON THE 5TH USE OF THE INSTRUMENT WITH 5 USES REMAINING. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW.THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THIS INSTRUMENT IS DESIGNED WITH TWO PITCH CABLES EACH WITH A CRIMP AT THE DISTAL END. IF A PITCH CABLE BREAKS AT THE DISTAL END, A CABLE SEGMENT AND/OR THE CRIMP COULD FALL INTO THE PATIENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.BLANK MDR FIELDS:FOLLOW-UP WAS ATTEMPTED, BUT PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE.THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE.FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE.INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE.FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A STEEL CABLE CONTROLLING THE CADIERE FORCEPS INSTRUMENT BROKE. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254714 ENDOWRIST;DAVINCI SI CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 420049-09 N10171024 280 00886874111338

    Patients

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