BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER- 29 MM

    MDR report key: 1112046 · Received August 8, 2008

    Report

    Report Number
    3005075853-2008-01024
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/08/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED LOW ANTERIOR RESECTION, THE DEVICE FIRED UNFORMED STAPLES AND THE ANASTOMOSIS HAD TO BE HANDSEWN. THERE WAS NOT ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER- 29 MM OCW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1