BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17936390 · Received October 13, 2023

    Report

    Report Number
    2955842-2023-19201
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS TESTING. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.186" X 0.597" WAS FOUND TO BE BROKEN OFF THE YAW PULLEY. THE BROKEN PIECE WAS RETURNED ATTACHED TO THE INSTRUMENT BY THE CONDUCTOR WIRE. GRIP TIP FRAGMENTS MAY RESULT WHEN THE METAL INJECTION MOLDING (MIM) IS NOT RETAINED TO THE OVERMOLD (OM) DURING USE. FURTHER INVESTIGATION FOUND A BROKEN MOLDED INSULATOR. THE MOLDED INSULATOR WAS BROKEN AT THE BASE OF THE GRIP. THE BROKEN SECTION MEASURED APPROXIMATELY 0.043" X 0.104" AND WAS NOT RETURNED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE MOLDED INSULATOR WAS OBSERVED TO POSSIBLY BE DAMAGED AND DISLODGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE TIP OF A FORCE BIPOLAR INSTRUMENT WAS BROKEN DURING A COLLISION WITH ANOTHER INSTRUMENT. THE BROKEN PIECE FELL INSIDE THE PATIENT¿S ANATOMY. THE CUSTOMER USED A BACKUP FORCE BIPOLAR INSTRUMENT TO CONTINUE WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683446 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10221113 0032 00886874120767

    Patients

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