BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS SINGLE USE TRIPLE LUMEN NEEDLE KNIFE

    MDR report key: 1847096 · Received September 22, 2010

    Report

    Report Number
    8010047-2010-00179
    Event Type
    Other
    Date Received
    September 22, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 24, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER WAS REPORTEDLY AWARE THAT THE NEEDLE KNIFE IS ONLY SUPPOSED TO BE USED IN PAPILLOTOMY (INCISION OF THE MAJOR DUODENAL PAPILLA) AND THAT IT WAS NOT INTENDED FOR THE AFOREMENTIONED PROCEDURE. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, BUT DID NOT RECEIVE ANY ADDITIONAL DETAILED INFORMATION. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT 4MM OF THE NEEDLE WAS MISSING. THE DEVICE WAS FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. IF ADDITIONAL SIGNIFICANT INFORMATION REGARDING THE REPORT IS RECEIVED LATER, THIS REPORT WILL BE UPDATED. 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 ESOPHAGO GASTRO DUODENOSCOPY (EGD) PROCEDURE, THE USER UTILIZED THE NEEDLE KNIFE TO CUT STRICTURE RINGS IN THE PATIENT'S ESOPHAGUS. THE STRICTURE RINGS WERE SAID TO BE COMPRISED OF SCAR TISSUE. THE DISTAL END OF THE NEEDLE REPORTEDLY DETACHED FROM THE DEVICE AND BECAME LODGED IN A RING OF SCAR TISSUE IN THE PATIENT'S ESOPHAGUS. THE PHYSICIAN ATTEMPTED TO USE A BIOPSY FORCEPS TO RETRIEVE THE DETACHED SECTION, WITHOUT SUCCESS. AN X-RAY WAS SAID TO HAVE BEEN PERFORMED THE FOLLOWING DAY, BUT THE NEEDLE TIP DID NOT APPEAR ON X-RAY. THE LOCATION OF THE FRAGMENT IS NOT KNOWN. THE PATIENT'S CURRENT CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE USE TRIPLE LUMEN NEEDLE KNIFE NEEDLE KNIFE FBK OLYMPUS MEDICAL SYSTEM CORPORATION KD-441Q 02K

    Patients

    Seq Age Sex Outcome Treatment
    1