BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 11127718 · Received January 6, 2021

    Report

    Report Number
    8010047-2021-00969
    Event Type
    Death
    Date Received
    January 6, 2021
    Report Date
    January 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCG
    PMA / PMN Number
    K151738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON DECEMBER 17, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "NEEDLE TRACT SEEDING AND ABSCESS ASSOCIATED WITH PANCREATIC FISTULA AFTER ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION". THIS STUDY WAS CONDUCTED ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION (EUS-FNA) FOR A (B)(6) YEARS OLD WOMAN WITH PANCREATIC DUCTAL ADENOCARCINOMA (PDA). IN THE LITERATURE, IT WAS REPORTED THAT NEEDLE TRACT SEEDING WITH SIMULTANEOUS ABSCESS ASSOCIATED WITH PANCREATIC FISTULA OCCURRING AFTER EUS-FNA FOR PDA. THE PATIENT PRESENTED WITH A FEVER OF 38 DEGREES CELSIUS AND ABDOMINAL DISCOMFORT 18 DAYS AFTER EUS-FNA FOR PDA OF THE PANCREATIC TAIL WITH A RETENTION CYST. AN ABSCESS ASSOCIATED WITH PANCREATIC FISTULA (APF) IS SECONDARY TO MAIN PANCREATIC DUCT INJURY WAS SUSPECTED. SIMULTANEOUS NEEDLE TRACT SEEDING WAS ALSO STRONGLY SUSPECTED BECAUSE THE EUS-FNA NEEDLE WAS BELIEVED TO PENETRATE THE MAIN PANCREATIC DUCT WITHIN THE TUMOR, CAUSING TUMOR CELLS TO COME INTO CONTACT WITH THE PANCREATIC JUICE WHICH SUBSEQUENTLY LEAKED OUT INTO THE NEEDLE TRACT. DISTAL PANCREATECTOMY WITH PARTIAL GASTRECTOMY WAS PERFORMED 4 MONTHS AFTER EUS-FNA. STRONG ADHESION BETWEEN THE STOMACH AND PANCREAS WAS OBSERVED. THE PANCREATIC BODY/TAIL, UPPER STOMACH, EUSFNA AND EUS-CD NEEDLE TRACT, TRANSVERSE COLON, LEFT ADRENAL GLAND, AND SPLEEN WAS REMOVED EN BLOC WITH CURATIVE INTENT DUE TO ADHESION AND SUSPECTED INVASION. THE POST-SURGICAL COURSE WAS COMPLICATED BY PANCREATIC FISTULA, WHICH WAS MANAGED CONSERVATIVELY. SHE PRESENTED WITH VOMITING 3 MONTHS LATER, WHEN SHE WAS DIAGNOSED WITH LIVER METASTASES, PERITONEAL CARCINOMATOSIS, AND DUODENAL OBSTRUCTION NEAR THE LIGAMENT OF TREITZ. SHE DIED 9 MONTHS AFTER THE NEEDLE TRACT SEEDING AND APF AND 5 MONTHS AFTER THE SURGERY. BASED ON THE AVAILABLE INFORMATION, DETAILED INFORMATION OF THE SUBJECT DEVICE WAS NOT PROVIDED. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) FOR NEEDLE TRACT SEEDING WITH SIMULTANEOUS ABSCESS ASSOCIATED WITH PANCREATIC FISTULA OCCURRING AFTER EUS-FNA WITH THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20993 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP. NA-U200H-8019S

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R