BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10646622 · Received October 7, 2020

    Report

    Report Number
    2955842-2020-11053
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 11, 2020
    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
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE SMALL GRASPING RETRACTOR INSTRUMENT WAS FOUND TO HAVE A LOOSE PITCH CABLE AT THE DISTAL END. THE INSTRUMENT WAS ALSO 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 INSTRUMENT WAS FOUND TO HAVE AN EXCESSIVE AMOUNT OF DRIED RESIDUE AROUND THE CLAMPING PULLEY CABLE GROOVES. THIS FAILURE IS MOST COMMONLY CAUSED BY IMPROPER REPROCESSING, SUCH AS INSUFFICIENT FLUSHING. SIGNS OF CORROSION WERE FOUND ON THE INSTRUMENT BEARINGS. PITCH AND GRIP INPUT DISK BEARINGS EXHIBITED ORANGE DISCOLORATION. IMPROPER CLEANING DURING REPROCESSING MOST COMMONLY CAUSES THIS FAILURE. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE 0.167¿ - 0.183 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. SYSTEM LOGS SHOWED THAT THE INSTRUMENT WAS LAST USED ON SYSTEM NUMBER (B)(4) ON (B)(6) 2020 AND IT HAD 0 LIVES REMAINING. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SMALL GRASPING RETRACTOR 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. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, IF THE FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    PRIOR TO STARTING A DA VINCI ASSISTED PROCEDURE THE SMALL GRASPING RETRACTOR HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104593 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 N10191007 0021 00886874112441

    Patients

    Seq Age Sex Outcome Treatment
    1