BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11449663 · Received March 10, 2021

    Report

    Report Number
    2955842-2021-10228
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 11, 2021
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "LOOSE CABLE". FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE SMALL GRASPING RETRACTOR 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. A SITE COMPLAINT HISTORY REVIEW WAS PERFORMED AND NO RELATED COMPLAINTS WERE FOUND. A REVIEW OF SYSTEM LOGS SHOWED THAT THE SMALL GRASPING RETRACTOR WAS LAST USED ON SYSTEM NUMBER SK0471 ON (B)(6) 2021 AND IT HAD 1 LIFE REMAINING. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: 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 NO PATIENT HARM WAS REPORTED, IF THE ISSUE WERE TO RECUR, IT COULD POTENTIALLY RESULT IN AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SMALL GRASPING RETRACTOR HAD A LOOSE CABLE. THERE WAS NO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER STATED THAT THE DEVICE WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349007 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 N10190515 0042 00886874112441

    Patients

    Seq Age Sex Outcome Treatment
    1