BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 19590556 · Received June 22, 2024

    Report

    Report Number
    2955842-2024-16165
    Event Type
    Malfunction
    Date Received
    June 22, 2024
    Date of Event
    May 28, 2024
    Report Date
    May 29, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR. THE BROKEN PIECE MEASURING APPROXIMATELY 0.327' X 0.144" IN SIZE, WAS RETURNED WITH THE INSTRUMENT. ADDITIONAL OBSERVATIONS FOUND RELATED TO THE REPORTED COMPLAINT STATES THAT THE INSTRUMENT HAD A DISLODGED GRIP TIP AS A RESULT OF THE BROKEN MOLDED INSULATOR. THE DISLODGED PIECE MEASURING APPROXIMATELY 0.663" X 0.191" IN SIZE, WAS RETURNED WITH THE INSTRUMENT. FURTHER, THE INSTRUMENT WAS FOUND WITH A BROKEN CONDUCTOR WIRE AT THE MOLDED INSULATOR. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. THE WIRE WAS FULLY BROKEN. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED. COMPONENTS ADJACENT TO THE BROKEN WIRE SHOWED DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SINGLE-PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE INSTRUMENT APPEARS TO HAVE A BROKEN MOLDED INSULATOR AND IS POTENTIALLY MISSING PIECES AT THE BASE OF THE BROKEN GRIP. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED PRIOR TO THE RETURN AND ANALYSIS OF THE INSTRUMENT. NO FURTHER ESCALATIONS REQUIRED FOR THE IMAGE REVIEW.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SINGLE-PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE ONE SIDE OF THE TIPS BROKEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE CUSTOMER INDICATED THAT THE INSTRUMENT TIP WAS NOT COMPLETELY BROKEN OFF. THERE WAS NO OBSERVED INTRAOPERATIVE COLLISION OR MISUSE INVOLVING THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104229 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10231110 0009 00886874114339

    Patients

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