BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19987607 · Received August 14, 2024

    Report

    Report Number
    2955842-2024-18032
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    May 27, 2024
    Report Date
    July 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2022-05-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ISI DID NOT ISSUE A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED AS THE CUSTOMER INFORMED THAT THE INSTRUMENT WAS NOT AVAILABLE FOR RETURN. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE SURGEON WAS USING A MEDIUM-LARGE CLIP APPLIER INSTRUMENT AND NOTICED WHILE ADVANCING THE CLIP APPLIER INTO THE PATIENT, THE JAWS UNINTENTIONALLY WERE STARTING TO CLOSE. HE MENTIONED HE WAS NOT CLOSING THE MASTER TOOL MANIPULATORS. HOWEVER, THE JAWS WERE CLOSING ON THEIR OWN AS HE WAS MOVING THE MTMS FORWARD. THIS UNINTENTIONAL BEHAVIOR RESULTED IN HIM NOT BEING ABLE TO USE THE CLIP APPLIER FOR THE VESSEL HE WAS TRYING TO OCCLUDE AND THUS HAD TO INTERVENE BY SUTURING. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE INSTRUMENT HAD NO CLIP FIRES LEFT AND WAS DISCARDED. SURGEON¿S INTENTION WAS TO APPLY A CLIP; HOWEVER, SINCE THE SURGEON NOTICED THE CLIP APPLIER'S JAWS WERE CLOSING WHILE INSERTING DEEPER IN THE PATIENT'S BODY, THE SURGEON WAS UNABLE TO APPLY THE CLIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A LAPAROSCOPIC CLIP APPLIER THROUGH THE ASSISTANT PORT. NO PATIENT INJURY WAS REPORTED. NO FRAGMENT FELL INTO THE PATIENT. IT CAUSED THE DELAY BETWEEN 15-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619435 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 N10200824 0094 00886874112465

    Patients

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