BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10782896 · Received November 3, 2020

    Report

    Report Number
    2955842-2020-11163
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 9, 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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SMALL GRASPING RETRACTOR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT "THE CABLE IS LOOSE.¿ FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CAB AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. A REVIEW OF THE INSTRUMENT LOG FOR THE SMALL GRASPING RETRACTOR (PART #470318-10/LOT#N10181203/SEQUENCE#0091) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE SMALL GRASPING RETRACTOR WAS LAST USED ON (B)(6) 2020 ON SYSTEM (B)(4). THE ALLEGED EVENT OCCURRED ON THE 2ND USE OF THE INSTRUMENT AND HAS 8 LIVES REMAINING. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. NO FURTHER ADVANCED TECHNICAL REVIEW ESCALATIONS REQUIRED. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A DAVINCI-ASSISTED SURGICAL PROCEDURE, A CABLE ON THE SMALL GRASPING RETRACTOR INSTRUMENT ALLEGEDLY WAS FOUND TO BE BROKEN. A BROKEN PITCH CABLE WAS IDENTIFIED DURING THE FAILURE ANALYSIS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A LOOSE CABLE WAS NOTED ON THE SMALL GRASPING RETRACTOR INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. 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
    1241390 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 N10181203 0091 00886874112441

    Patients

    Seq Age Sex Outcome Treatment
    1