BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERCEPTRE MODULAR INSTRUMENT

    MDR report key: 1913077 · Received December 2, 2010

    Report

    Report Number
    1219602-2010-00293
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    January 13, 2010
    Report Date
    June 22, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING EVALUATED BY (B)(4). REPORT FURNISHED BY (B)(4) CONFIRMED TWO DUAL ACTION LINKS ARE MISSING FROM THE DEVICE. DEVICE SHOWED NOMINAL WEAR. (B)(4).

    Description of Event or Problem · 1

    PATIENT ALLEGES FAILURE OF A INTERCEPTRE LAPAROSCOPIC GRASPER USED DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE PERFORMED ON (B)(6), 2010 . THE SURGEON IS UNSURE IF THE MISSING SMALL METAL PIECE OF THE INSTRUMENT HAD FALLEN INSIDE PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERCEPTRE MODULAR INSTRUMENT DUAL ACTION ATRAUMATIC GRASPER KOG SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7205629 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1