BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 767808 · Received October 6, 2006

    Report

    Report Number
    2647580-2006-00418
    Event Type
    Injury
    Date Received
    October 6, 2006
    Date of Event
    September 29, 2006
    Report Date
    October 2, 2006
    Manufacturer
    PONCE-USS
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, AFTER FIRING FOR LAR/END TO END ANASTOMOSIS, THE DEVICE COULD NOT BE REMOVED SMOOTHLY SINCE THE TISSUE WAS UNCUT PARTIALLY. SINCE THE SURGEON PULLED THE DEVICE BY FORCE, THE TISSUE WAS DAMAGED. AFTER THAT, FIRED AGAIN ANOTHER DEVICE FOR LAR/DST. THIS FIRING WAS PERFORMED PROPERLY. THE SURGEON DID NOT CONSIDER THAT THE TISSUE WAS THICK. NO EXCESSIVE BLEEDING. LOT NUMBER IS P6E542 OR P5B1146. SEX: MALE. PROCEDURE: LAR/END TO END ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GAG PONCE-USS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention