BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BEACON NEEDLE

    MDR report key: 15067390 · Received July 20, 2022

    Report

    Report Number
    3004904811-2022-00007
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    February 27, 2022
    Report Date
    July 20, 2022
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE: TITLE: ACCURACY AND CLINICAL OUTCOMES OF PANCREATIC EUS-GUIDED FINE-NEEDLE BIOPSY IN A CONSECUTIVE SERIES OF 852 SPECIMENS. SOURCE: DOI: 10.4103/EUS-D-21-00180. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM 2015 TO 2020, A RETROSPECTIVE STUDY OF 723 PATIENTS WERE EVALUATED FOR THE USE OF THE A NEEDLE FOR PANCREATIC ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY PROCEDURES WHICH CONSISTED OF 852 SAMPLES. ONE PATIENT DEVELOPED ACUTE PANCREATITIS 3 HOURS AFTER PROCEDURE AND WAS DISCHARGED TWO DAYS LATER, 28 PATIENTS HAD SELF-LIMITING LOCAL BLEEDING DURING THE PROCEDURE, 17 PATIENTS COMPLAINED OF ABDOMINAL PAIN AND WERE ALL DISCHARGED THE SAME DAY AS THE PROCEDURE, 40 PATIENTS WERE ADMITTED TO A HOSPITAL WITHIN 7 DAYS AFTER THE PROCEDURE AND THESE WERE LATE COMPLICATIONS AND 10 PATIENTS HAD IMMEDIATE COMPLICATIONS AVERAGE TIME ADMITTED WAS 7.9 DAYS. ONE PATIENT WAS ADMITTED FOR 114 DAYS, SUFFERING FROM SEVERE NECROTIC PANCREATITIS WITH ABSCESS UNDERGOING NECROSECTOMY, AND ADMISSION TO THE INTENSIVE CARE UNIT FOR A TOTAL OF 40 DAYS. ONE PATIENT WAS HOSPITALIZED FOR 25 DAYS WITH BLEEDING AND UNDERWENT GASTRODUODENOSCOPY IN GENERAL ANESTHESIA, SHOWING DUODENAL BLEEDING, MOST LIKELY CAUSED BY THE TRANS-DUODENAL ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY PROCEDURE AND WAS TREATED BY ENDOSCOPIC THERAPY ONLY AND 2 PATIENTS NEEDED INTERVENTION. 20 PATIENTS WITH ACUTE PANCREATITIS, 13 PATIENTS COMPLAINED WHO OF ABDOMINAL PAIN, 2 PATIENTS WITH SELF-LIMITING BLEEDING, 1 PATIENT WITH INFECTION, 1 PATIENT WITH SEPSIS AND 1 PATIENT WITH FEVER HAD BEEN HOSPITALIZED FOR AN AVERAGE OF 4.6 DAYS REQUIRING ONLY CONSERVATIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358323 UNKNOWN BEACON NEEDLE BIOPSY NEEDLE FCG COVIDIEN LP BARRX UNKNOWN BEACON NEEDLE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R