BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKESLEY THRUBITE FORCEPS

    MDR report key: 2443658 · Received January 26, 2012

    Report

    Report Number
    1037007-2012-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    November 16, 2011
    Report Date
    January 26, 2012
    Manufacturer
    GYRUS MEDICAL GMBH
    Product Code
    KAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AS OF (B)(4) 2012. NO INJURY REPORTED. NO OTHER COMPLAINTS FOR THIS PART NUMBER IN 2 YEARS. ORIGINALLY REPORTED BY USER FACILITY, REPORT (B)(4). ORIGINALLY REPORTED AS PART NUMBER 23-0728, HOWEVER, WHEN CONTACTED TO INVESTIGATE THE USER FACILITY STATED THAT WAS AN ERROR AND THE ACTUAL PART NUMBER IS 335801.

    Description of Event or Problem · 1

    PT WAS UNDERGOING A TRANSSPHENOIDAL RESECTION OF A PITUITARY TUMOR. DURING SURGERY THE NASAL FORCEP BROKE OFF INSIDE THE PT. BOTH PIECES WERE RETRIEVED AND THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKESLEY THRUBITE FORCEPS KAE GYRUS MEDICAL GMBH 03055663/HX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other