BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULATED SHEATH

    MDR report key: 3554806 · Received December 27, 2013

    Report

    Report Number
    1418479-2013-00037
    Event Type
    Injury
    Date Received
    December 27, 2013
    Date of Event
    December 1, 2013
    Report Date
    December 17, 2013
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AS THE ACTUAL DEVICE WAS RETURNED TO THE RWMIC FACILITY ON 12/18/2013. NO ISSUES FOUND WITH DEVICE. DEVICE HISTORY: MANUFACTURED 05/2012, SOLD ON 09/14/2012 NO RECORD OF ANY REPAIRS OR ROUTINE MAINTENANCE OF DEVICE. NO SIMILAR COMPLAINTS IN THE LAST FIVE YEARS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFO, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) A PT RETURNED TO HOSPITAL AFTER A BARIATRIC PROCEDURE AND IS CURRENTLY IN FOR A PROLONGED STAY. THERE WERE MANY INSTRUMENTS USED DURING THE PROCEDURE. TWO HAVE BEEN IDENTIFIED AS BEING MANUFACTURED BY RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (B)(4) FORCEPS INSERT (8393.182) (B)(4). INSULATED SHEATH (8393.913) (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677561 INSULATED SHEATH INSULATED SHEATH FED RICHARD WOLF GMBH 8393.913 112Y12

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization