BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCULAR STAPLER PROXIMATE HCS HEMORROIDAL

    MDR report key: 253070 · Received December 7, 1999

    Report

    Report Number
    1527736-1999-06265
    Event Type
    Malfunction
    Date Received
    December 7, 1999
    Date of Event
    November 10, 1999
    Report Date
    November 10, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE (1) EMS AND THE (1) PPH01 WERE USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE EMS STAPLES WOULD NOT FEED AND THE (1) PPH01 CUT BUT STAPLED PARTIALLY. THE CASE WAS COMPLETED WITH ANOTHER INSTRUMENT AND THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCULAR STAPLER PROXIMATE HCS HEMORROIDAL CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, INC. NA M4ER6U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other