BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 258486 · Received January 4, 2000

    Report

    Report Number
    9610877-1999-00001
    Event Type
    Injury
    Date Received
    January 4, 2000
    Date of Event
    November 9, 1999
    Report Date
    December 30, 1999
    Manufacturer
    ASAHI OPTICAL CO., LTD. MEDICAL INSTRUMENTS DIVISION
    Product Code
    FDF
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 11/09/1999, A ROUTINE COLONOSCOPY PROCEDURE WAS PERFORMED ON A PATIENT. THE PENTAX VIDEOCOLONOSCOPE WAS INSERTED WITHOUT DIFFICULTY. AFTER THE PROCEDURE, THE PATIENT COMPLAINED ABOUT PAIN. X-RAYS OF THE PATIENT CONFIRMED A PERFORATION. EXACT LOCATION OF PERFORATION IS UNKNOWN (INFORMATION WAS UNAVAILABLE TO FACILITY CONTACT). THE FACILITY HAS FILED AN INTERNAL "VARIANCE REPORT" ABOUT THIS EVENT. THIS IN-HOUSE REPORT DID NOT IDENTIFY NOR DESCRIBE THIS (EVENT) AS A PROBLEM WITH THE ENDOSCOPE. MANUFACTURER'S CONTACT AT FACILITY WAS ASKED TO HAVE DOCTOR CONTACT MANUFACTURER TO PROVIDE MORE DETAILS ABOUT EVENT. TO DATE, DOCTOR HAS NOT CONTACTED MANUFACTURER WITH ANY MORE INFORMATION. BASED UPON ALL THE INFORMATION RECEIVED TO DATE, IT APPEARS THAT THIS IS ANOTHER EXAMPLE OF A KNOWN RISK (PERFORATION) INHERENT WITH THIS TYPE OF ENDOSCOPIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX COLONOSCOPE FDF ASAHI OPTICAL CO., LTD. MEDICAL INSTRUMENTS DIVISION EC-3830LK *

    Patients

    Seq Age Sex Outcome Treatment
    1 *