BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS BIOPSY FORCEPS

    MDR report key: 2123500 · Received June 9, 2011

    Report

    Report Number
    8010047-2011-00117
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 11, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVAL. THE EVAL FOUND THAT THERE WAS AN EXTENSIVE AMOUNT OF FOREIGN MATERIALS ADHERED TO THE BROKEN CUP. THERE WAS EVIDENCE OF CORROSION AND DENTS ON THE DISTAL END. THE MFG HISTORY WAS REVIEWED FOR THE DEVICE, WITH NO ANOMALIES OR IRREGULARITIES REPORTED. IT WAS CONCLUDED THAT INSUFFICIENT REPROCESSING LIKELY CAUSED THE CORROSION AND DENTS ON THE DISTAL END. THE BREAKAGE LIKELY OCCURRED WHEN FORCE WAS APPLIED DURING CLOSING OF THE FORCEPS, DUE TO DECREASED STRENGTH OF THE CUPS RESULTING FROM CORROSION AND/OR PHYSICAL IMPACT. NO FURTHER ACTION IS REQUIRED AT THIS TIME AND THIS REPORT IS DEEMED CLOSE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A BRONCHOSCOPY WITH TRANSBRONCHIAL LUNG BIOPSY, ONE OF THE BIOPSY FORCEP CUPS BROKE OFF AND FELL INSIDE THE PT'S LUNGS AFTER A TISSUE SAMPLE WAS OBTAINED. THE BROKEN PIECE WAS RETRIEVED FROM THE PT WITH THE USE OF AN UNK MODEL OF FORCEPS. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BIOPSY FORCEPS BIOPSY FORCEPS KGE OLYMPUS MEDICAL SYSTEMS CORPORATION FB-52C-1 OZK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention