BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLOSE TROCAR SITE

    MDR report key: 2896255 · Received December 28, 2012

    Report

    Report Number
    1219930-2012-01040
    Event Type
    Injury
    Date Received
    December 28, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K954853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AS REPORTED IN THE OBESITY SURGERY, JUNE 2011, VOL. 21, ISSUE 6 (DOI 10.1007/S11695-011-0400-7) IN AN ARTICLE ENTITLED: LAPAROSCOPIC REINFORCED SLEEVE GASTRECTOMY: EARLY RESULTS AND COMPLICATIONS, ANGRISANI L, CUTOLO PP, BUCHWALD JN, MCGLENNON TW, NOSSO G, PERSICO F, CAPALDO B, SAVASTANO S., ONE HUNDRED TWENTY-ONE PTS UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY WITH PERI-STRIP REINFORCEMENT. FROM JAN 2003 TO DEC 2006, SIXTEEN PTS HAD THE SLEEVE GASTRECTOMY AS PART OF A STAGED BARIATRIC PROCEDURE AND ONE HUNDRED FIVE HAD THE SLEEVE GASTRECTOMY AS THE PRIMARY PROCEDURE. THE STUDY NOTES THAT BOTH ETHICON AND COVIDIEN STAPLERS WERE USED. ONE EXTRALUMINAL BLEED AT THE TROCAR SITE, WHICH WAS TREATED WITH A BLOOD TRANSFUSION. PT EXPERIENCED AN EXTRALUMINAL BLEED AT THE TROCAR SITE. PT WITH POSTOPERATIVE BLEEDING EXPERIENCED A DECREASE OF HEMOGLOBIN FROM 14.5 TO 11.0 MG/DL WITHIN THE FIRST 24 POSTOPERATIVE HRS; NO BLOOD DRAINAGE THROUGH THE DRAINAGE TUBE POSITIONED CLOSE TO THE EXCISION LINE. CT SHOWED IN POD1 A LARGE PROPERITONEAL BLOOD COLLECTION NEAR LEFT TROCAR SITE. TREATMENT - TREATED WITH RBC BLOOD TRANSFUSION. OUTCOME RESOLUTION WITHIN 48 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLOSE TROCAR SITE DISPOSABLE SUTURING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R