BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA

    MDR report key: 10086518 · Received May 26, 2020

    Report

    Report Number
    2647580-2020-01635
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    June 26, 2015
    Report Date
    May 26, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523005554
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: HARTMANN¿S PROCEDURE AND LAPAROSCOPIC REVERSAL VERSUS PRIMARY ANASTOMOSIS AND ILEOSTOMY CLOSURE FOR LEFT COLONIC PERFORATION SOURCE: LANGENBECKS ARCH SURG (2015) 400:609¿616, DOI 10.1007/S00423-015-1319-6. RECEIVED: 16 MARCH 2015 /ACCEPTED: 16 JUNE 2015 /PUBLISHED ONLINE: 26 JUNE 2015, # SPRINGER-VERLAG BERLIN HEIDELBERG 2015. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN AUGUST 2010 AND MARCH 2014, COMPARING HARTMANN¿S PROCEDURE AND LAPAROSCOPIC REVERSAL VERSUS PRIMARY ANASTOMOSIS AND ILEOSTOMY CLOSURE FOR LEFT COLONIC PERFORATION, THE CIRCULAR STAPLER WAS USED DURING THE LAPAROSCOPIC HARTMAN REVERSAL. SEVENTEEN OUT OF 24 PATIENTS WENT THRU WITH THE LAPAROSCOPIC HARTMAN REVERSAL PROCEDURE. MAJOR POST-REVERSAL COMPLICATIONS WERE ONE ANASTOMOTIC LEAKAGE AND ONE ASPIRATION PNEUMONIA REQUIRING MECHANICAL VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551423 EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EEA31 10884523005554

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention