BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17688865 · Received September 6, 2023

    Report

    Report Number
    2955842-2023-18243
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 8, 2023
    Report Date
    August 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, NOTING THAT THE INSTRUMENT HAD BROKEN JAWS. AN INVESTIGATION WAS COMPLETED TO DETERMINE, THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT WITH THE TECH SUPPORT ENGINEER (TSE), WHO RECOMMENDED THE INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY. AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE ROOT CAUSE OF THE ALLEGED INSTRUMENT BREAKAGE CANNOT BE DETERMINED, BASED ON THE INFORMATION PROVIDED AND PHONE SUPPORT DETAILS. THE TSE RECOMMENDED, THE SITE RETURN THE BROKEN INSTRUMENT FOR FAILURE ANALYSIS. THE INSTRUMENT HAS NOT BEEN RETURNED AS OF THIS TIME. THE PHONE SUPPORT DETAILS DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA ETEP SURGICAL PROCEDURE. IT WAS DISCOVERED, THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT JAWS WERE BROKEN OFF. THE STAFF TOOK TWO X-RAYS, AND WERE UNABLE TO LOCATE THE INSTRUMENT TIPS IN THE PATIENT. THE SURGEON BELIEVED, THE TIPS WERE MISSING WHEN THE INSTRUMENT WAS INITIALLY INSTALLED. THE STAFF INSTALLED A NEW INSTRUMENT AND COMPLETED THE PROCEDURE WITH NO ISSUES. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT DEMOGRAPHIC INFORMATION AVAILABLE. THE INSTRUMENT WAS BROKEN, BEFORE IT WAS INITIALLY USED. THE BROKEN PIECES WERE FOUND IN THE BOTTOM OF THE SONIC MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870167 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 N/A

    Patients

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