BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10839726 · Received November 13, 2020

    Report

    Report Number
    2955842-2020-11197
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 22, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112745
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS OBTAINED THAT REVEALED THE INSTRUMENT INVOLVED IN THIS EVENT WAS A VESSEL SEALER EXTEND. REFER TO THE UPDATED PRODUCT INFORMATION IN SECTION D. D11 - INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE VESSEL SEALER EXTEND INSTRUMENT INVOLVED WITH THIS COMPLAINT. THE CUSTOMER REPORTED ISSUE WAS REPLICATED/CONFIRMED. FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF GRIP TIPS BROKEN TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE VESSEL SEALER EXTEND INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP TIP OVERMOLD. A PIECE APPROXIMATELY 0.188" X 0.327" PART WAS BROKEN OFF AND NOT RETURNED WITH THE INSTRUMENT. NO OTHER DAMAGE WAS FOUND AND THE REVIEW OF THE LOGS SHOWED NO FAILURES. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THE VESSEL SEALER INSTRUMENT INVOLVED WITH THIS COMPLAINT TO BE RETURNED FOR FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT BEEN RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. A REVIEW OF THE INSTRUMENT LOG FOR THE VESSEL SEALER ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE VESSEL SEALER (940322-07/ M10190324-0043) WAS LAST USED ON (B)(6) 2020 ON SYSTEM SK2535. THE ALLEGED EVENT OCCURRED ON THE 1ST USE OF THE INSTRUMENT. THE INSTRUCTIONS FOR USE FOR THE DA VINCI INSTRUMENTS INCLUDES THE FOLLOWING: WARNING: TO PREVENT DAMAGE TO THE INSTRUMENT, ALWAYS STRAIGHTEN THE INSTRUMENT WRIST UNDER ENDOSCOPIC VISUALIZATION BEFORE REMOVING THE INSTRUMENT THROUGH THE CANNULA. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING THE REMOVAL OF THE VESSEL SEALER FROM THE PATIENT, THE SURGEON DID NOT COMPLETELY STRAIGHTEN THE INSTRUMENT WRIST PRIOR TO REMOVAL, RESULTING IN DAMAGE TO THE INSTRUMENT. FRAGMENTS FROM THE BROKEN VESSEL SEALER INSTRUMENT FELL INSIDE THE PATIENT AND ONLY SOME OF THE FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES REPORTED. AT THIS TIME, THE PATIENT'S CURRENT STATUS, AND WHETHER THE PATIENT RETURNED TO THE HOSPITAL DUE TO COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT ARE UNKNOWN. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, DURING THE REMOVAL OF THE VESSEL SEALER FROM THE PATIENT, THE SURGEON DID NOT COMPLETELY STRAIGHTEN THE INSTRUMENT WRIST PRIOR TO REMOVAL, RESULTING IN DAMAGE TO THE INSTRUMENT. FRAGMENTS FROM THE BROKEN VESSEL SEALER INSTRUMENT FELL INSIDE THE PATIENT ,AND ONLY SOME OF THE FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED ISSUES. 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
    1304539 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L92200728 10886874112745

    Patients

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