BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 17397747 · Received July 26, 2023

    Report

    Report Number
    2955842-2023-17316
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 13, 2023
    Report Date
    June 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) IS UNABLE TO DETERMINE THE CAUSE OF THE STAPLE LINE HEMATOMA. DESPITE DENIAL OF INTRAOPERATIVE ISSUES OR A COMPROMISED STAPLE LINE, THE SURGEON ASSUMES THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS A STAPLER MALFUNCTION. THE PRODUCT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION AND WAS CONFIRMED TO HAVE BEEN DISCARDED. SYSTEM OR INSTRUMENT LOGS WERE UNAVAILABLE AS THE PROCEDURE INFORMATION COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY, THERE WAS A LARGE HEMATOMA NOTED ON THE STAPLE LINE. THE FOLLOWING INFORMATION WAS OBTAINED/CLARIFIED THROUGH FOLLOW UP WITH THE SURGEON: THERE WERE NO INTRAOPERATIVE ISSUES, BUT THE SURGEON DID NOTE THAT NORMALLY HE USES ONE BLUE RELOAD AND THE REST WHITE BUT FOR THIS PROCEDURE HE USED 2 BECAUSE THIS PATIENT HAD A THICKER STOMACH AND THERE WERE A LOT OF PAUSES FOR COMPRESSION ON THE FIRST BLUE RELOAD. SEVERAL HOURS AFTER SURGERY, THE PATIENT BECAME TACHYCARDIC AND HAD A CHANGE IN LAB VALUES WHICH PROMPTED A COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED AN 8 CM HEMATOMA DISTALLY ALONG THE GASTRIC WALL OF THE SLEEVE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), TRANSFUSED WITH 2 UNITS OF BLOOD, AND EVENTUALLY STABILIZED WITHOUT ANY OTHER INTERVENTION AND DISCHARGED ON POST-OPERATIVE DAY 3. THE SURGEON COULD NOT CONFIRM THE HEMATOMA WAS IN A LOCATION THAT A BLUE RELOAD WAS USED BUT DID SAY IT "PROBABLY" WAS. THE PATIENT WAS DISCHARGED HOME AND HAS EXPERIENCED ONGOING DYSPHAGIA, IS ON A LIQUID DIET, AND IS CURRENTLY AWAITING AN ENDOSCOPY TO CHECK FOR MANUAL COMPRESSION FROM THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630432 SUREFORM STAPLER 60 RELOAD GDW INTUITIVE SURGICAL, INC 48360 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES