BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 15124552 · Received July 28, 2022

    Report

    Report Number
    2955842-2022-13208
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 29, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111659
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TENACULUM FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF PITCH CABLE BROKEN 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 NOT INSTALLED IN THE CLEVIS. PITCH CABLE BREAKAGE OCCURS WHEN TENSILE LOAD EXCEEDS THE ULTIMATE STRENGTH OF THE MATERIAL. THE PITCH CABLE CONSTRUCTION IS DESIGNED TO OPTIMIZE LOAD AN FATIGUE (CYCLING) CHARACTERISTICS. VARIATION IN CUSTOMER USE CONDITION, PROCEDURE TYPE, PATIENT ANATOMY, PRODUCT HANDLING, INSTRUMENT TIP LENGTHS, GRIP TORQUE, AND MANUFACTURING TOLERANCES ARE A FEW VARIABLES WHICH CAN INFLUENCE PITCH CABLE FAILURE. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE WAS THAT THE INSTRUMENT WAS FOUND TO HAVE CORROSION ON ONE OR MORE CLAMPING PULLEYS IN THE BACKEND. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, MOST COMMONLY CAUSED BY IMPROPER CLEANING/ REPROCESSING TECHNIQUES. SIGNS OF CORROSION WERE FOUND ON THE INSTRUMENT BEARINGS. PITCH AND GRIP INPUT DISK BEARINGS EXHIBIT ORANGE DISCOLORATION. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, MOST COMMONLY CAUSED BY IMPROPER CLEANING/REPROCESSING TECHNIQUE. NO INVESTIGATION REQUIRED AS NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE TENACULUM FORCEPS INSTRUMENT (PART#: 420207-10/ LOT/SERIAL#: (B)(4) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE TENACULUM FORCEPS INSTRUMENT WAS LAST USED ON 25-MAY-2022 VIA SYSTEM RSH0163 FOR MYOMECTOMY SURGICAL PROCEDURE. THERE WERE 6 USES REMAINING AFTER THIS LAST USAGE. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS FOUND THE TENACULUM FORCEPS INSTRUMENT TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. IF A PITCH CABLE BREAKS AT THE DISTAL END, A CABLE SEGMENT AND/OR THE CRIMP COULD POTENTIALLY FALL INSIDE A PATIENT. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, A RECURRENCE OF THE FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN WIRE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN THE INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332869 ENDOWRIST;DAVINCI SI TENACULUM FORCEPS NAY INTUITIVE SURGICAL, INC 420207-10 N10210920 677 00886874111659

    Patients

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