BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON SURGICAL BLADES 15

    MDR report key: 1578876 · Received December 31, 2009

    Report

    Report Number
    2523190-2009-00004
    Event Type
    Malfunction
    Date Received
    December 31, 2009
    Report Date
    December 31, 2009
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS PREVIOUSLY SUBMITTED ON 09/28/2009 UNDER #1221336-2009-00004 ((B) (6) FACILITY) IN ERROR. IT IS BEING RE-ISSUED USING THE CORRECT FACILITY NUMBER AT THIS TIME - MILTEX. THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. THE INVESTIGATORS REPORT THAT THE ROOT CAUSE IS UNDETERMINED. POSSIBLE MANUFACTURING PROBLEM, BUT MOST LIKELY TOO MUCH PRESSURE APPLIED CAUSING THE BLADE TO BREAK. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    THE RN SUPERVISOR REPORTED VIA TELEPHONE. THE DOCTOR RECORDED IN THE PATIENT'S CHART THAT THE TIP OF THE #15 BLADE BROKE WHERE IT ATTACHED TO THE SCALPEL HANDLE DURING AN OPEN RHINOPLASTY WITH SEPTOPLASTY, BILATERAL INFERIOR TURBINATE INFRACTURE AND MUCOSAL COAGULATION. HE WAS UNABLE TO LOCATE/REMOVE THE ONE BROKEN PIECE. AN X-RAY SHOWED THE PIECE OF BLADE IN THE PATIENT'S STOMACH. IT WAS REMOVED VIA ENDOSCOPY WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBON SURGICAL BLADES 15 M5 - GENERAL SURGERY GES C08F02

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR