BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10452800 · Received August 26, 2020

    Report

    Report Number
    2955842-2020-10794
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 31, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112434
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 MEGA SUTURECUT NEEDLE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE INSTRUMENT WAS ALSO FOUND TO HAVE BLADE DAMAGE. BOTH BLADE EDGES WERE INDENTED, WHICH PREVENTS THE BLADES FROM CLOSING. 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. SYSTEM LOGS SHOWED THAT THE INSTRUMENT WAS LAST USED ON SYSTEM NUMBER (B)(4) ON (B)(6) 2020 AND IT HAD 1 LIFE REMAINING. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE THE MEGA SUTURECUT NEEDLE 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 REPORTED PATIENT INJURY, IF THE FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A DA VINCI ASSISTED PROCEDURE, THE MEGA SUTURECUT NEEDLE HAD A BROKEN WIRE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, THE REPORTER STATED THAT SHE HAD PROVIDED AL THE INFORMATION WHILE RETURNING THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918600 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 470309-14 N10180622 00886874112434

    Patients

    Seq Age Sex Outcome Treatment
    1