BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14796688 · Received June 24, 2022

    Report

    Report Number
    2955842-2022-12371
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 24, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112441
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SMALL GRASPING RETRACTOR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FA FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, 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. 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. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE SMALL GRASPING RETRACTOR INSTRUMENT (470318-10/N10190819 0102) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022. THIS COMPLAINT IS BEING REPORTED BASED ON 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE GRASPING RETRACTOR INSTRUMENT WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER DID NOT HAVE ANY ADDITIONAL INFORMATION. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WAS REQUESTED, HOWEVER THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240457 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 N10190819 0102 00886874112441

    Patients

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