BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN SGS

    MDR report key: 17720451 · Received September 11, 2023

    Report

    Report Number
    3012481535-2023-00008
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 28, 2023
    Manufacturer
    STANDARD BARIATRICS
    Product Code
    GDW
    PMA / PMN Number
    K210278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING DAY AFTER A SLEEVE GASTRECTOMY PROCEDURE USING THE TITAN SGS STAPLER, THE PATIENT HAD SEVERE NAUSEA AND VOMITING. AFTER ATTEMPTS TO MANAGE PATIENT'S SYMPTOMS, IT WAS NOTED THAT THE PATIENT HAD A HIGH HEART RATE COMPARED TO NORMAL. IT WAS THEN NOTED VIA CT SCAN THAT A LARGE CLOT HAD APPEARED IN THE PATIENT'S ABDOMEN. IN THE EVENING, IT WAS DECIDED THAT THE TEAM SHOULD RE-OPERATE. ON OBSERVATION OF THE ABDOMEN, A LARGE CLOT WAS NOTICED NEAR THE RESECTED STAPLE LINE OF THE STOMACH. AFTER ISOLATING, THERE WAS A SMALL CONTINUOUS BLEED, THE STAPLE LINE WAS OVERSEWN, AND A HEMOSTATIC AGENT WAS APPLIED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143941 TITAN SGS SURGICAL STAPLER WITH STAPLE, IMPLANTABLE GDW STANDARD BARIATRICS SGS23R NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R