BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15X12MM DSP TNG LLETZ LOOP

    MDR report key: 1983268 · Received February 2, 2011

    Report

    Report Number
    1717344-2011-00071
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 14, 2011
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS DISCARDED BY THE SITE. THE SITE HAS RETURNED A NON-INCIDENT UNUSED SAMPLE FOR EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PART OF THE DEVICE BROKE OFF DURING THE PROCEDURE AND FELL INTO THE PT. THE PIECE WAS RETRIEVED BY THE SURGEON. THE EXACT DATE IS UNK BUT IT OCCURRED IN (B)(6). THERE WAS NO PT INJURY. THE INCIDENT SAMPLE WAS DISCARDED AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15X12MM DSP TNG LLETZ LOOP ELECTROSURGICAL ACCESSORY GEI 0510E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK