BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA INSTRUMENT

    MDR report key: 8778789 · Received July 10, 2019

    Report

    Report Number
    1219930-2019-04040
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    February 19, 2019
    Report Date
    July 10, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL COMPARING REINFORCED STAPLERS WITH BARE STAPLERS DURING DISTAL PANCREATECTOMY (HISCO-07 TRIAL). SOURCE SOCIETY OF SURGICAL ONCOLOGY 2019. (2019) 26:1519¿1527. RECEIVED: 7 OCTOBER 2018 PUBLISHED ONLINE: 19 FEBRUARY 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF A STUDY PERFORMED FROM JULY 2016 AND DECEMBER 2017 REGARDING WHETHER REINFORCED STAPLERS REDUCE THE INCIDENCE OF CLINICALLY RELEVANT PANCREATIC FISTULA (PF) AFTER DISTAL PANCREATECTOMY (DP) COMPARED WITH STAPLERS WITHOUT REINFORCEMENT. A TOTAL OF 119 PATIENTS WERE ANALYZED. REINFORCED STAPLER WAS USED UN 61 PATIENTS WHILE BARE STAPLER WAS USED IN 59 PATIENTS. IT WAS REPORTED THAT COMPLICATIONS INCLUDE: 12 STAPLE LINE HEMORRHAGE, 8 DAMAGE TO PARENCHYMA AT STAPLING LINE, 66 PANCREATIC FISTULA. ADDITIONAL COMPLICATIONS REPORTED INCLUDE: 14 INTRA-ABDOMINAL ABSCESS, 2 POST-OPERATIVE HEMORRHAGE, 2 WOUND INFECTION, 3 REOPERATION, 4 READMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570266 UNKNOWN ENDO GIA INSTRUMENT STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R