BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20948128 · Received December 16, 2024

    Report

    Report Number
    2955842-2024-23118
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    November 19, 2024
    Report Date
    November 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2022-05-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WERE 2 MEDIUM-LARGE CLIP APPLIER INSTRUMENTS USED IN THIS PROCEDURE; IT IS UNKNOWN WHICH WAS INVOLVED WITH THE REPORTED EVENT: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER (LOT #K1223022-0199) AND PERFORMED FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE ONE BENT GRIP, CAUSING THEM TO BE MISALIGNED. THE OFFSET AT THE TIPS WAS 0.34MM. THE GRIPS WERE NOT FOUND TO BE CRACKED. ISI ALSO RECEIVED MEDIUM-LARGE CLIP APPLIER INSTRUMENT (LOT #K13221204-0109) AND PERFORMED FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE ONE BENT GRIP, CAUSING THEM TO BE MISALIGNED. THE OFFSET AT THE TIPS WAS 0.35MM. THE GRIPS WERE NOT FOUND TO BE CRACKED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED, AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AN UNSUCCESSFUL CLIP APPLICATION TO THE LEFT HEPATIC ARTERY RESULTED IN BLEEDING AND THE PROCEDURE WAS CONVERTED TO OPEN. THE ISSUE OCCURRED WHEN A MEDIUM-LARGE (ML) GREEN HEM-O LOC CLIP, APPLIED USING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT, FAILED TO LOCK AND BROKE. THE UNEXPECTED BLEEDING RESULTED IN AN ESTIMATED BLOOD LOSS OF APPROXIMATELY 300MLS. TO CONTROL AND RESOLVE THE BLEEDING, A BULLDOG CLAMP WAS APPLIED, AND THE PROCEDURE WAS CONVERTED TO AN OPEN APPROACH. ANY MEDICAL INTERVENTIONS PERFORMED AFTER THE CONVERSION ARE UNKNOWN; HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION, THE CUSTOMER APPLIED A HEM-O-LOK CLIP ON THE LEFT HEPATIC ARTERY USING A MEDIUM-LARGE CLIP APPLIER INSTRUMENT. TWO CLIP APPLIER INSTRUMENTS WERE USED. AN UNSPECIFIED NUMBER OF CLIPS ALLEGEDLY BROKE DURING THE SURGERY, CAUSING BLEEDING WHICH WAS CONTROLLED USING A BULLDOG CLAMP. ALTHOUGH THE BLOOD LOSS VOLUME IS UNKNOWN, IT WAS NOTED THAT THERE WAS NOT A LOT OF BLOOD LOSS. THE PROCEDURE WAS THEN CONVERTED TO OPEN SURGERY. IT IS UNKNOWN WHICH MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ASSOCIATED WITH THE BROKEN CLIPS. IT IS UNKNOWN IF A CLIP OR DEVICE FRAGMENT FELL INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279619 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K12230226 0199

    Patients

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