BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 2896072 · Received December 27, 2012

    Report

    Report Number
    1219930-2012-01037
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COVIDIEN, FORMERLY U.S. SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. AS REPORTED IN LITERATURE: REINFORCING THE STAPLE LINE DURING LAPAROSCOPIC SLEEVE GASTRECTOMY: PROSPECTIVE RANDOMIZED CLINICAL STUDY COMPARING THREE DIFFERENT TECHNIQUES, SEVENTY-FIVE PTS UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) EVALUATING THREE DIFFERENT TECHNIQUES OF HANDLING THE STAPLES LINE DURING LSG. FROM (B)(6) 2008 TO (B)(6) 2009, FOUR PTS EXPERIENCED A POSTOPERATIVE LEAK (5.33%). THESE FOUR POSTOPERATIVE LEAKS DEVELOPED BETWEEN POD 11 AND POD 35 AND REQUIRED SOME PROCEDURAL INTERVENTION. THERE WAS ONE SUBPHRENIC HEMATOMA THAT DEVELOPED IN A PT. PT FROM THE SEAMGUARD REINFORCEMENT GROUP EXPERIENCED A POSTOPERATIVE LEAK ON POD 30, TREATMENT: PLACED PERCUTANEOUS DRAIN, TRANSFORMING THE LEAK INTO A GASTROCUTANEOUS FISTULA; OUTCOME: COMPLETE FISTULA HEALTH WAS REACHED ON POD74.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO GIA SULU DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY U.S. SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R