BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 19611795 · Received June 26, 2024

    Report

    Report Number
    2955842-2024-16289
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114285
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DISLODGED GRIP KNOB, THE GRIP KNOB WAS RETURNED WITH THE INSTRUMENT. NO OBVIOUS DAMAGE TO THE GRIP SHAFT WAS OBSERVED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS RETURNED WITH A BROKEN TUBE ADAPTER. THE BROKEN PIECES MEASURED APPROXIMATELY 0.083" X 0.064" AND 0.074" X 0.063" IN SIZE, WERE NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT'S DISLODGED GRIP KNOB WAS INVESTIGATED FURTHER. THE GRIP KNOB APPEARS TO HAVE BEEN DISLODGED AND WAS RETURNED. THE GRIP KNOB WAS DISASSEMBLED FOR INSPECTION AND ALL INTERNAL COMPONENTS APPEAR TO BE PRESENT. INSPECTION OF THE RETAINING RING GROOVE ON THE GRIP SHAFT FOUND THE DEPTHS TO BE APPROXIMATELY 72.5 MICROMETERS AND 109 MICROMETERS. THE DRAWING AND DATASHEET FOR THE RETAINING RING SPECIFIES A GROOVE DEPTH OF 0.004" OR APPROXIMATELY 102 MICROMETERS. HOWEVER, THE DRAWING FOR THE GRIP SHAFT DOES NOT SPECIFY A GROOVE DEPTH AND THEREFORE THE GROOVE DEPTH ON THE SHAFT IS NEITHER CONTROLLED OR INSPECTED. SINCE THE GROOVE DEPTH IS NOT SPECIFIED BY THE PART DRAWING, THE PART IS TECHNICALLY CONFORMING, HOWEVER IT DOES NOT MEET THE SPECIFIED GROOVE DEPTH FOR THE RETAINING RING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI REVIEWED THE SITE¿S COMPLAINT HISTORY, WHICH DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE DEVICE DESIGN. NO ADDITIONAL ACTIONS ARE CURRENTLY REQUIRED GIVEN THAT THIS ISSUE WILL CONTINUE TO BE TRACKED PER (B)(4) (QUALITY DATA REVIEW MEETINGS). AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS OBTAINED, THEN THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) TO STATE THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT GRAY DISK CAME OFF. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688985 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-57 K10230923 0012 00886874114285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES