BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22541102 · Received July 18, 2025

    Report

    Report Number
    2955842-2025-30398
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 24, 2025
    Report Date
    June 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. SYSTEM/INSTRUMENT LOG REVIEW COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION. THIS MANUFACTURER REPORT CAPTURES FRAGMENT FALL INTO THE PATIENT. MANUFACTURER REPORT NUMBER 2955842-2025-30397 CAPTURES THE BLEEDING FROM THE STAPLE LINE DURING THE SAME PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT OF THE BLUE RELOAD BROKE OFF AND FELL INTO THE PATIENT FOLLOWING THE FIRING OF A SUREFORM 60 STAPLER INSTRUMENT. THE EVENT RESULTED IN AN INCOMPLETE STAPLE LINE AND SUBSEQUENT BLEEDING, WHICH WAS CONTROLLED USING A SUCTION IRRIGATOR INSTRUMENT. TO ADDRESS THE RETAINED FRAGMENT, AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED, AND THE FRAGMENT WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED AS PLANNED. IN RELATION, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH REPORT UF/IMPORTER REPORT # (B)(4). "FROM STAFF: A SMALL FRAGMENT OF BLUE PLASTIC STAPLE LOAD WAS INCORPORATED IN THE STAPLE LINE OF THE PTS [PATIENT'S] SLEEVE GASTRECTOMY. IT WAS NOTICED AND REMOVED BY THE SURGEON. UPON REMOVAL, THE STAPLE LINE OF THE STOMACH BEGAN TO BLEED. THE STAPLE LINE WAS OVERSEWN WITH SUTURE AND THE SURGEON PERFORMED AN EGD [ESOPHAGOGASTRODUODENOSCOPY] LEAK TEST TO ENSURE THERE WAS NOT A PERFORATION. THE SURGEON THEN IRRIGATED WITH SALINE. AS A RESULT, THIS ADDED AN ADDITIONAL 20 MINUTES OF SURGICAL INTERVENTION. FROM OPERATIVE REPORT: AN INITIAL GREEN LOAD WAS USED FOLLOWED BY SUBSEQUENT FIRINGS OF A BLUE LOAD. THE 2ND FIRE HAD A BLUE FIBER TO LOOK LIKE A PIECE OF PLASTIC FROM THE STAPLER. THEREFORE, I CHOSE TO PERFORM AN EGD AND OVERSEWED THE STAPLE LINE AND DO A LEAK TEST. WHEN APPROACHING THE LAST FIRE AN ANGLE OF HIS WE WERE CAREFUL NOT TO INCLUDE THE DISTAL ESOPHAGUS BY COMPLETING OUR STAPLE FIRING BETWEEN THE LEFT CRUS OF THE DIAPHRAGM AND THE SPLEEN. THE STAPLE LINE WAS OVERSEWN WITH A PERMANENT STRATAFIX STYLE SUTURE IN A RUNNING HORIZONTAL MATTRESS FASHION." INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426728 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-09 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES