BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 2896032 · Received December 27, 2012

    Report

    Report Number
    1219930-2012-01036
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COVIDIEN, FORMERLY US 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). INITIAL REPORT SENT TO FDA ON: (B)(4) 2012.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. AS REPORTED IN LITERATURE: REINFORCING THE STAPLE LINE DURING LAPAROSCOPIC SLEEVE GASTRECTOMY: (B)(4) CLINICAL STUDY COMPARING THREE DIFFERENT TECHNIQUES, SEVENTY-FIVE PATIENTS UNDERWENT (B)(4) EVALUATING THREE DIFFERENT TECHNIQUES OF HANDLING THE STAPLE LINE DURING (B)(4). FROM (B)(6) 2008 TO (B)(6) 2009, FOUR PATIENTS EXPERIENCED A POSTOPERATIVE LEAK (5.33%). THESE FOUR POSTOPERATIVE LEAKS DEVELOPED BETWEEN POD 11 AND POD 35 AND REQUIRED PROCEDURAL INTERVENTION. THERE WAS ONE SUBPHRENIC HEMATOMA THAT DEVELOPED IN A PATIENT. PATIENT FROM THE NO REINFORCEMENT GROUP EXPERIENCED A POSTOPERATIVE LEAK ON POD 35. TREATMENT: PLACED COVERED METALLIC ENDOSCOPIC STENT. OUTCOME: COMPLETE FISTULA HEALING WAS REACHED ON POD 87.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO GIA SULU NONE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R