BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCULAR STAPLER PROXIMATE HCS HEMORROIDAL

    MDR report key: 317987 · Received February 26, 2001

    Report

    Report Number
    1527736-2001-00858
    Event Type
    Malfunction
    Date Received
    February 26, 2001
    Date of Event
    January 23, 2001
    Report Date
    January 23, 2001
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A HEMIORRHOIDECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT WHEN THE SURGEON FIRED THE PPH01 HEMMORRHOID STAPLER, TWO STAPLES DID STAY ON THE STAPLER. THESE STAPLES LOOKED LIKE HALF WAY OUT OF THE STAPLER. SINCE THERE WAS AN OPENING, THE SURGEON HAD TO SUTURE THE TISSUE BY HAND TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7687 CIRCULAR STAPLER PROXIMATE HCS HEMORROIDAL CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other