BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 14548280 · Received May 31, 2022

    Report

    Report Number
    8010047-2022-09111
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 13, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCG
    UDI-DI
    04953170380525
    PMA / PMN Number
    K151738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND A CORRECTION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE "CASE REPORT TRANSJEJUNAL ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DRAINAGE FOR PANCREATIC JEJUNOSTOMY STRICTURE USING A FORWARD-VIEWING ECHOENDOSCOPE IN A PATIENT WITH ALTERED ANATOMY."     LITERATURE SUMMARY: PANCREATIC JEJUNOSTOMY STRICTURE (PJS) IS ONE OF THE MAJOR LATE COMPLICATIONS AFTER PANCREATICODUODENECTOMY. ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DRAINAGE (EUS-PD) IS CONSIDERED A SALVAGE TREATMENT FOR SYMPTOMATIC PJS AFTER ENDOSCOPIC RETROGRADE PANCREATOGRAPHY FAILURE; HOWEVER, THE TECHNICAL SUCCESS RATE OF THE ENDOSCOPIC TREATMENT OF PJS REMAINS UNSATISFACTORY, MAINLY DUE TO SURGICALLY ALTERED ANATOMY. HEREIN, WE DESCRIBE A CASE OF PJS SUCCESSFULLY TREATED WITH TRANSJEJUNAL EUS-PD USING A FORWARD-VIEWING ECHOENDOSCOPE. A (B)(6) MAN WHO SUFFERED FROM REPETITIVE SEVERE BACK PAIN DUE TO PJS WAS REFERRED TO OUR HOSPITAL. SINCE TRANSGASTRIC EUS-PD WAS DIFFICULT, WE ATTEMPTED TRANSJEJUNAL EUS-PD USING A FORWARD-VIEWING ECHOENDOSCOPE. TO FACILITATE SCOPE INSERTION, WE FIRST STRAIGHTENED THE AFFERENT JEJUNA! LOOP AND PLACED A STIFF GUIDEWIRE. WITH THIS SCHEME, WE SUCCESSFULLY PERFORMED TRANSJEJUNAL EUS-PD AND PLACED A 5-FR PLASTIC STENT. IN CONCLUSION, THIS TECHNIQUE IS USEFUL FOR TREATING PATIENTS WITH PJS WHEN TRANSGASTRIC EUSPD IS DIFFICULT.     TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: ACUTE PANCREATITIS N=1.   THIS ARTICLE INCLUDES 3 REPORTS: PATIENT IDENTIFIER (B)(6): NA-U200H-8019, THE LITERATURE DESCRIBED "19G EZ SHOT 3PLUS", WE SELECTED "NA-U200H-8019" AS A REPRESENTATIVE PRODUCT. PATIENT IDENTIFIER (B)(6): (B)(4). PATIENT IDENTIFIER (B)(6): (B)(4). THIS REPORT IS 1 OF 3 FOR PATIENT IDENTIFIER (B)(6): NA-U200H-8019, THE LITERATURE DESCRIBED "19G EZ SHOT 3PLUS", WE SELECTED "NA-U200H-8019" AS A REPRESENTATIVE PRODUCT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS. THE AUTHOR STATED: IT IS POSSIBLE THAT THE SLIGHT SHIFT IN THE PUNCTURE POSITION CONTRIBUTED TO PANCREATIC LEAKAGE FROM THE SIDE HOLE OF THE PUNCTURE NEEDLE, BUT THERE IS NO PRODUCT PROBLEM. THE AUTHOR PROVIDED THE MODEL NUMBER AS NA-U200H-8022S (LOT UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883105 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP. NA-U200H-8022S UNKNOWN(LITERATURE) 04953170380525

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other UNKNOWN SERIAL: (B)(6)