BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 2276059 · Received October 3, 2011

    Report

    Report Number
    2518897-2011-00004
    Event Type
    Injury
    Date Received
    October 3, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 30, 2011
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    EOQ
    PMA / PMN Number
    K023376
    Removal / Correction Number
    CORRECTION REMOVAL NUMBE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY RETURNED THE (B)(4) VIDEO BRONCHOSCOPE INVOLVED IN THE EVENT FOR EVAL. INITIAL INVESTIGATION INDICATES REPAIR TECHNICIAN ERROR; EXCESS SILICONE SEALANT WAS APPLIED IN THE BIOPSY INLET T-PIECE DURING AN EARLIER ROUTINE REPAIR OF THE AFFECTED DEVICE. THERE ARE 20 ENDOSCOPES WITH SIMILAR DESIGN WHICH HAD BEEN REPAIRED BY THE TECHNICIAN THAT WILL BE RECALLED AND REPAIRED. FURTHER INVESTIGATION IS ONGOING. THE REPORTER INDICATED THE FACILITY INTENDED TO SEND A REPORT TO THE FDA HOWEVER PENTAX HAS NOT RECEIVED A COPY OF THE REPORT. EVAL METHOD: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. METHOD: T-PIECE CONNECTOR; JOINT.

    Description of Event or Problem · 1

    DR. (B)(6) INSERTED THE SCOPE INTO THE PT. AFTER INITIAL VIEWING HE THEN DID THE 'WASH' USING A 20 CC SYRINGE. THE DOCTOR THEN 'PASSED' A SINGLE USE CYTOLOGY BRUSH THROUGH THE ENDOSCOPE AND NOTICED A BLACK PIECE OF MATERIAL IN THE PT. THE DOCTOR REMOVED THE CYTOLOGY BRUSH, INSERTED A BIOPSY FORCEPS, AND WITHDREW THE SCOPE WHILE GRASPING THE FOREIGN OBJECT WITH THE FORCEPS. THE DOCTOR COMPLETED THE PROCEDURE WITH NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO BRONCHOSCOPE EOQ PENTAX MEDICAL COMPANY EB-1570K *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BENTON DICKINSON 20 CC SYRINGE| BOSTON SCIENTIFIC RADIAL EDGE PULMONARY STANDARD| (B)(4)| COOK MEDICAL SINGLE USE CYTOLOGY BRUSH:| CAPACITY SINGLE USE BIOPSY FORCEPS