BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENS CLEANING SHEATH

    MDR report key: 3577133 · Received October 10, 2013

    Report

    Report Number
    8010047-2013-00531
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    June 1, 2013
    Report Date
    August 21, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE RETURNED TO OLYMPUS MEDICA SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE TUBE TORN NEAR THE DISTAL TIP AND THE DISTAL TIP SEPARATED FROM THE SUBJECT DEVICE. THERE WERE SCRATCHES IN THE TUBE NEAR THE DISTAL TIP AND UP ANGLE SIDE. IN ADDITION, THERE WERE SOME DAMAGES IN THE TUBE NEAR THE DISTAL TIP. THERE WAS NO IRREGULARITY IN THE MANUFACTURING RECORD DURING THE SUBJECT DEVICE LOT WERE MANUFACTURED. THE SCRATCH AND DAMAGE OF THE TUBE NEAR THE DISTAL TIP POSSIBLY WAS MADE BY A TROCAR WHEN THE USER FACILITY WITHDREW THE SUBJECT DEVICE FROM THE TROCAR WITH EXCESSIVE FORCE. OMSC CONCLUDED THAT THE SEPARATION OF THE DISTAL TIP POSSIBLY OCCURRED WHEN THE USER FACILITY WITHDREW THE VIDEOSCOPE WITH THE SUBJECT DEVICE ATTACHED, AND THE VIDEOSCOPE WAS ANGULATED. 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 AN UNCERTAIN SURGICAL PROCEDURE, THE DOCTOR FOUND THE DISTAL PART OF THE SUBJECT DEVICE LYING FREELY IN THE PATIENT. THERE WAS NO OTHER PATIENT INJURY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519430 LENS CLEANING SHEATH LENS CLEANING SHEATH GCJ OLYMPUS MEDICAL SYSTEMS CORPORATION MAJ-1537 08A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK