BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY DRAINAGE

    MDR report key: 3856367 · Received April 9, 2014

    Report

    Report Number
    8010047-2014-00174
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 14, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K933200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT WAS NOT RETURNED TO OMSC FOR INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT THERE IS A POSSIBILITY OF THE BREAKAGE OF FLAPS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME.

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT WAS REQUIRED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE INVESTIGATION CONFIRMED THAT ALL OF THE 4 SIDE FLAPS ON THE PROXIMAL PORTION WERE BROKEN OFF. THE DEVICE BECAME BLACK. THERE WERE NO ABNORMALITIES ON FLAPS OF THE DISTAL PORTION. THE FRACTURE SURFACE OF THE FLAP SHOWED NO STRETCH MARK. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, THERE WAS NOTHING ABNORMAL DETECTED. BASED ON THE FINDING THAT THERE WAS NO STRETCH MARK ON THE FLAPS, THE FLAP WAS BROKEN OFF, BECAUSE THE FLAPS MAY HAVE BEEN DETERIORATED DUE TO THE PATIENT'S DIGESTIVE JUICES AND PERISTALTIC MOTION. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE WARNS; �E AFTER PLACING THE DRAINAGE TUBE IN THE DUCT, CLOSELY MONITOR THE CONDITION OF THE PATIENT. ALSO PERIODICALLY CHECK THE CONDITION OF THE DRAINAGE TUBE (TO SEE IF THE LUMEN OF THE TUBE IS NOT CLOGGED, AND IF THERE ARE FOUR SIDE FLAPS IN THE SIDE OF THE DUODENUM, ETC.) AND THE CONDITION OF IMPLANTATION OF THE TUBE (TO SEE IF THE POSITION OF THE TUBE HAS NOT CHANGED). IN CASE OF IRREGULARITIES OR UNNECESSARY RETENTION OF THE DRAINAGE TUBE, REMOVE THE DRAINAGE TUBE USING GRASPING FORCEPS. IF NECESSARY, PERIODICALLY EXCHANGE THE DRAINAGE TUBE. THE DRAINAGE TUBE MAY DETERIORATE OVER TIME AND COULD BECOME CLOGGED. THE STATUS OF THE DRAINAGE TUBE CAN CHANGE WITH THE CONDITION OF THE PATIENT (E.G., INFLAMMATION, REMITTANCE OF BILIARY TRACT STENOSIS, ETC.). THE DRAINAGE TUBE MAY DETERIORATE OVER TIME, CAUSING THE SIDE FLAP TO BREAK OR DETACH COMPLETELY (REPORTS HAVE BEEN RECEIVED ON SIDE FLAPS COMING OFF SEVERAL MONTHS AFTER PLACEMENT). DETERIORATION OR DAMAGE OF THE DRAINAGE TUBE MAY RESULT IN EROSION OF THE DUODENAL WALL, BILIARY TRACT OBSTRUCTION, DETACHMENT OF THE DRAINAGE TUBE PART MIGRATING INTO THE DUCT OR OUT OF THE PAPILLA, MUCOUS MEMBRANE DAMAGE, PERFORATION, OR BLEEDING. �E WHEN THE DRAINAGE TUBE IN THE DUODENAL SIDE IS DAMAGED AND FRAGMENTS SUCH AS FLAPS COME OFF INSIDE THE DUODENUM, USE GRASPING FORCEPS FOR RETRIEVAL. ALSO FOR WHAT REMAINED IN THE BILE DUCT SIDE, USE GRASPING FORCEPS FOR RETRIEVAL OR REPLACE IT WITH A NEW ONE. �E DO NOT REPOSITION THE DRAINAGE TUBE (PBD-421-1004 TO 1015, PBD-422-1003 TO 1015) IN PATIENT BODIES WHO HAVE SUSTAINED THE DETACHMENT OF EVEN ONE SIDE FLAP OF THE PLACED DRAINAGE TUBE. DEPENDING ON THE INDIVIDUAL, MATERIAL DETERIORATION OF THE PLACED DRAINAGE TUBE OVER TIME CAN RESULT IN ANOTHER DETACHMENT OF SIDE FLAP(S). THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MED SYSTEMS CORP (OMSC) WAS REPORTED THAT THE USER FACILITY DETECTED THAT THE PROXIMAL END OF THE FLAPS WERE MISSING WHEN THE DOCTOR RETRIEVED THE STENT. THE PT IS REPORTEDLY IN HOSP AND THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214404 BILIARY DRAINAGE BILIARY DRAINAGE FGE OLYMPUS MEDICAL SYSTEMS CORPORATION PBD-421-1004 36K

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR