BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 3233985 · Received July 16, 2013

    Report

    Report Number
    3001845648-2013-00064
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE - "DURING PLACING THE STENT IN THE PANCREATIC DUCT VIA A RUBBER CAP ATTACHED TO THE ENDOSCOPY CHANNEL, THE POSITIONING SLEEVE DROPPED IN THE CHANNEL AND THEN DROPPED INTO THE PATIENT'S BODY. THE PHYSICIAN DID NOT REMOVE IT IN THE ANTICIPATION THAT IT WILL BE EXCRETED WITH THE STOOL." THE DEVICE (POSITIONING SLEEVE) INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND NO IMAGES WERE PROVIDED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS PER THE COMPLAINT DESCRIPTION; DURING PLACEMENT OF THE STENT IN THE PANCREATIC DUCT, THE POSITIONING SLEEVE DROPPED IN THE CHANNEL AND THEN DROPPED INTO THE PATIENT'S BODY. AS PER IFU18922-0410, "THE POSITIONING SLEEVE IS NOT INTENDED FOR USE IN THE ACCESSORY CHANNEL OF THE ENDOSCOPE." THEREFORE, IT IS MOST LIKELY THAT THE ROOT CAUSE OF THIS COMPLAINT AS PER THE DETAILS ABOVE IS USER ERROR, AS THE POSITIONING SLEEVE IS NOT INTENDED FOR USE IN THE ACCESSORY CHANNEL. HOWEVER, AS THE CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED, THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. UPON NOTICING THAT THE POSITIONER HAD FALLEN INTO THE PATIENT'S BODY, THE PHYSICIAN DECIDED NOT TO TAKE ANY ACTION. IN THIS CASE THE PATIENT DID NOT SUFFER A DEATH OR SERIOUS INJURY. IT HAS BEEN DETERMINED THAT THE POSITIONER HAS SINCE BEEN EXCRETED BY THE PATIENT. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AS THE DEVICE (POSITIONING SLEEVE) INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND NO IMAGES WERE PROVIDED. PRE-EXISTING PATIENT CONDITION WAS BILE DUCT STONE. THE ACTUAL LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT IS UNKNOWN, HOWEVER, POSSIBLE LOT NUMBERS PROVIDED ARE C839163 OR C840054. LOT # C839163 WAS MANUFACTURED ON 17-DECEMBER-2012 WITH AN EXPIRY DATE OF 14-DECEMBER-2015. LOT # C840054 WAS MANUFACTURED ON 19-DECEMBER-2012 WITH AN EXPIRY DATE OF 19-DECEMBER-2015. THERE WERE NO GPDS-5-5 DEVICES OF LOT # C839163 OR LOT # C840054 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. PRIOR TO DISTRIBUTION, GEENEN PANCREATIC STENT DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER C839163 AND C840054 REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. GPDS-5-5 DEVICES ARE INTENDED FOR SINGLE USE ONLY AND ARE USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS. AS PER IFU18922-0410, "THE POSITIONING SLEEVE IS NOT INTENDED FOR USE IN THE ACCESSORY CHANNEL OF THE ENDOSCOPE." IN ADDITION, AS PER NOTES SECTION OF IFU "RETAIN THE POSITIONING SLEEVE FOR USE WHEN INTRODUCING THE STENT FLAPS INTO THE ACCESSORY CHANNEL." THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THIS COMPLAINT REPRESENTS AN ISOLATED OCCURRENCE FOR THIS RPN. QUALITY ENGINEERING ASSESSED THE COMPLAINT USING THE HEALTH RISK ASSESSMENT (HRA) SCALE FOR SEVERITY, OCCURRENCE AND PROBABILITY OF INJURY AND THE RISK HAS BEEN DETERMINED TO BE LOW. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    (B)(6) 2013: DURING PLACING THE STENT IN THE PANCREATIC DUCT VIA A RUBBER CAP ATTACHED TO THE ENDOSCOPY CHANNEL, THE POSITIONING SLEEVE DROPPED IN THE CHANNEL AND THEN DROPPED INTO THE PATIENT BODY. THE PHYSICIAN DID NOT REMOVE IT IN THE ANTICIPATION THAT IT WILL BE EXCRETED WITH THE STOOL. (B)(6) 2013: THE POSITIONING SLEEVE GOT STUCK IN THE ASCENDING COLON (NOT PENETRATED THE WALL) AND THE PATIENT COMPLAINED OF PAIN. THE PATIENT BECAME HOSPITALIZED AND TREATED BY ADMINISTRATION OF MEDICINE. THE POSITIONING SLEEVE WAS NOT REMOVED BECAUSE ACCESSING THE SITE IN THE ASCENDING COLON WAS DIFFICULT. DATE UNKNOWN: THE POSITIONING SLEEVE WAS NOT SEEN AT THE SITE BY FLUOROSCOPY, SO THE PHYSICIAN DETERMINED IT WAS EXCRETED WITH THE STOOL. THE PATIENT WAS TREATED BY ADMINISTRATION OF MEDICINE AND NOT IN SERIOUS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329957 GEENEN PANCREATIC STENT SET FGE COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization