BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE USE ASPIRATION NEEDLE NA-U200H

    MDR report key: 15487560 · Received September 26, 2022

    Report

    Report Number
    9614641-2022-00366
    Event Type
    Death
    Date Received
    September 26, 2022
    Report Date
    November 28, 2022
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCG
    UDI-DI
    04953170380402
    PMA / PMN Number
    K151738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. . 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 RECEIVED FROM THE AUTHORING PHYSICIAN AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. B5: UPDATED WITH INFORMATION RECEIVED FROM THE AUTHORING PHYSICIAN. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICES COULD NOT BE REVIEWED SINCE THE SERIAL NUMBERS WERE 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 AUTHOR SAID THAT AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT ADVERSE EVENTS AND DEATH DESCRIBED IN THIS LITERATURE. IN ADDITION, THE MALFUNCTION OF THE DEVICE HAS NOT BEEN REPORTED, AND FROM CLINICAL/MEDICAL EVALUATION AND RISK ASSESSMENT, IT IS LIKELY THAT THE REPORTED EVENT IS AN ACCIDENT OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE USING THE SUBJECT DEVICE. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PATIENTS WITH INFECTED WALLED-OFF NECROSIS: WHICH STENT TO CHOOSE?" LITERATURE SUMMARY: THIS SINGLE-CENTER RETROSPECTIVE STUDY OF A PROSPECTIVELY COLLECTED DATABASE OF ALL SYMPTOMATIC PANCREATIC FLUID COLLECTION (PFC) PATIENTS WHO UNDERWENT EUS-GUIDED DRAINAGE. AMONG 120 PATIENTS WITH PFC (108 WALLED-OFF NECROSIS (WON), 22 PSEUDOCYST) WHO UNDERWENT EUS-GUIDED DRAINAGE, THERE WAS NO DIFFERENCE IN OUTCOME PARAMETERS IN BIFLANGED METAL STENTS (BFMS) AND DOUBLE PIGTAIL PLASTIC STENTS (DPPS) GROUPS. AMONG PATIENTS WITH WON, CLINICAL SUCCESS WAS SIGNIFICANTLY HIGHER (96.2% VS. 81.8%, P=0.04), WITH SIGNIFICANTLY SHORTER HOSPITAL STAY (6 VS. 10 D) AND PROCEDURE DURATION (17.18 ± 4.6 VS. 43.6 ± 9.7 MIN, P<.0001) IN THE BFMS GROUP.. AMONG PATIENTS WITH INFECTED WON WITH/WITHOUT ORGAN FAILURE (OF), THE CLINICAL SUCCESS WAS SIGNIFICANTLY HIGHER (100% VS. 73.9%) IN BFMS COMPARED WITH DPPS GROUP. THE DURATION OF THE PROCEDURE WAS SIGNIFICANTLY LOWER (16.28 ± 4.4 VS. 44.39 ± 10.7, P<.0001) IN BFMS COMPARED WITH DPPS GROUP THIS STUDY CONCLUDED THAT EUS-GUIDED DRAINAGE OF WON USING BFMS SCORES OVER DPPS. IN PATIENTS HAVING INFECTED WON WITH/WITHOUT OF, BFMS MAY BE PREFERRED OVER DPPS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [DPPS] (N = 60), BLEED - 4 PATIENTS, PERFORATION - 1 PATIENT, STENT MIGRATION - 1 PATIENT, RECURRENCE OF COLLECTION - 2 PATIENTS, MORTALITY - 2 PATIENTS. [BFMS] (N = 60), BLEED - 1 PATIENT, STENT MIGRATION - 2 PATIENTS, RECURRENCE OF COLLECTION - 1 PATIENT. FOR THE "EZ SHOT3 PLUS" DESCRIBED IN THE LITERATURE, WE SELECTED THE "NA-U200H-8019" WITH THE LARGEST NUMBER OF SHIPMENTS IN THE REGION AND DURING THE STUDY PERIOD, AND CREATED ETQ. SINCE THERE IS NO OLYMPUS DEVICE CALLED "UCT 180", "GF-UCT180" WAS SELECTED. FROM THE ABOVE, 6 COMPLAINTS WERE CREATED BECAUSE THE LITERATURE INCLUDES PATIENT DEATHS. (B)(4): NA-U200H-8019(FOR DEATH OF PATIENTS), (B)(4): NA-U200H-8019(FOR ADVERSE EVENTS OTHER THAN DEATH), (B)(4): GF-UCT180 (FOR DEATH OF PATIENTS), (B)(4): GF-UCT180 (FOR ADVERSE EVENTS OTHER THAN DEATH), (B)(4): GIF-HQ190 (FOR DEATH OF PATIENTS), (B)(4): GIF-HQ190 (FOR ADVERSE EVENTS OTHER THAN DEATH). THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 0

    THE AUTHORING PHYSICIAN CONFIRMED THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS REPORTED IN THE ARTICLE. THE DEVICE IS NOT AVAILABLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077128 SINGLE USE ASPIRATION NEEDLE NA-U200H SINGLE USE ASPIRATION NEEDLE FCG AOMORI OLYMPUS CO., LTD. NA-U200H-8019 UNKNOWN(LITERATURE) 04953170380402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death UNK SERIAL: GF-UCT180, GIF-HQ190.