BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNK)

    MDR report key: 1002982 · Received February 5, 2008

    Report

    Report Number
    1527736-2008-00687
    Event Type
    Injury
    Date Received
    February 5, 2008
    Date of Event
    September 4, 2002
    Report Date
    January 21, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LETTER FROM THE ATTORNEY FOR THE PATIENT, DURING A SURGERY FOR REMOVAL OF ENDOMETRIOSIS, THE PATIENT SUFFERED DUAL PERFORATION OF THE BOWEL. UNKNOWN IF THERE WAS AN ISSUE WITH THE DEVICE. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNK) LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other GENERATOR| HANDPIECE