BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19005252 · Received March 29, 2024

    Report

    Report Number
    2955842-2024-12848
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 6, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE ONE SEVERELY BENT GRIP, CAUSING MISALIGNMENT OF THE GRIPS. THE GRIPS DID NOT SHOW CRACKING DAMAGE. COMPONENTS ADJACENT TO THIS SEVERELY BENT GRIP DID NOT SHOW DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLIP APPLIER WAS UNABLE TO RELEASE THE CLIP AND BECAME STUCK WHILE CLIPPING THE CYSTIC DUCT AND ARTERY. THE SURGEON STRUGGLED WITH GETTING THE INSTRUMENT OFF WITHOUT CAUSING DAMAGE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR WITH NO NOTED DAMAGE. THE CUSTOMER USED THE FORCE/FENESTRATED BIPOLAR INSTRUMENTS TO ASSIST IN PRYING OPEN TO HELP RELEASE. ROBOTICS COORDINATOR BELIEVES THE SURGEON ALSO ATTEMPTED TO GET THE INSTRUMENT TO RELEASE BY DISENGAGING IT FROM THE FIELD. ESTIMATED BLOOD LOSS WAS 10-25 CC¿S. THERE WAS NO BLOOD NEEDED. THE INSTRUMENT WAS REMOVED IMMEDIATELY AND ISOLATED THEN AN ADDITIONAL MED/ CLIP APPLIER WAS OPENED TO FINISH THE PROCEDURE ROBOTICALLY. THE CUSTOMER BELIEVES A CLIP DID FALL INTO THE PATIENT AND WAS RETRIEVED WITH A DIFFERENT INSTRUMENT AND PLACED IN A SPECIMEN POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583684 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K11230928 0205 00886874112465

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES