BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 20860917 · Received December 6, 2024

    Report

    Report Number
    2955842-2024-22666
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 8, 2024
    Report Date
    November 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE THE SUREFORM 45 STAPLER INSTRUMENT OR THE GREEN RELOAD ACCESSORY THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. INSTRUMENT AND SYSTEM LOG REVIEWS COULD NOT BE PERFORMED DUE TO INSUFFICIENT PRODUCT INFORMATION. A REVIEW OF THE PROVIDED IMAGES WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER, AND SHOWED ONE STAPLE IN AN OPEN OR U SHAPE WAS CONFIRMED. THERE DOES NOT APPEAR TO BE ANY ACTIVE BLEEDING LOCAL TO THIS STAPLE. THE ROOT CAUSE OF THE REPORTED ISSUES ALONE IS UNDETERMINABLE. MALFORMED STAPLES CAN OCCUR IF HARD OBJECTS (LIKE STAPLES FROM PREVIOUS FIRES) OBSTRUCT THE DEPLOYMENT OF THE KNIFE AND/OR STAPLES. REFER TO SECTION H10: RELATED REPORT NUMBER 1 FOR MEDWATCH REGARDING THE SUREFORM 45 BLUE RELOAD ACCESSORY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE FIRING EVENTS OCCURRED AT THE COMPLETION OF THE POSTERIOR OBLIQUE FISSURE; RESULTING IN STAPLE FORMATIONS SIMILAR TO "C" AND "X". THE STAPLES THAT WERE CAUGHT IN THE PULMONARY ARTERY WERE CAREFULLY REMOVED AND THE MINIMAL BLOOD LOSS FROM THE LUNG PARENCHYMA WAS RESOLVED BY COAGULATING THE TISSUE DISTAL TO THE STAPLES USING A BIPOLAR ENERGY DEVICE. AS A RESULT OF THE FIRING EVENTS, UNPLANNED TISSUE WAS REMOVED; HOWEVER, THE PROCEDURE WAS COMPLETED AND STILL RESULTED IN A SUCCESSFUL, ACCEPTABLE SURGICAL OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AFTER FIRING A SUREFORM 45 STAPLER INSTRUMENT WITH A BLUE RELOAD ACCESSORY, THE STAPLES BECAME DISLODGED, OPENED/UNSTAPLED, CATCHING ON THE ARTERY. IN AN ATTEMPT TO RESOLVE THE ISSUE A BACKUP SUREFORM 45 GREEN RELOAD ACCESSORY WAS USED; HOWEVER, THE ISSUE PERSISTED, AND SOME STAPLES DID NOT "STICK TO THE TISSUE". HOW THE STAPLER ISSUE WAS RESOLVED IS UNKNOWN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201613 SUREFORM SUREFORM 45 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48345G UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES