MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombocytopenia (4431)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "performance of endoscopic ultrasound-guided versus percutaneous liver biopsy in diagnosing stage 3¿4 fibrosis." this is a single center, retrospective chart review among patients with liver diseases at a tertiary endoscopy center from february 2011 to march 2020.We assessed the eus-guided biopsy (eus-bx) versus percutaneous liver biopsy (p-bx) outcomes by success rate, performance, and safety profile.The primary outcome was the association between eus-bx clinical variables and the presence of histologic liver fibrosis stage = 3.The secondary outcomes were the associations between eus-bx and variables indicative of fibrosis.Results: fifty-nine patients underwent eus-bx; and 59, p-bx.All eus-bx procedures were successfully completed.All 56/56 (100%) of eus-bx vs.50/52 (96.2%) p-bx were considered adequate samples.Tissue lengths were significantly longer in the eus-bx cohort (p < 0.0001) with a trend towards a greater number of portal tracts.46/56 (82.1%) cases of eus-bx vs.32/52 (61.5%) of p-bx had > 10 portal tracts; 21/56 (37.5%) cases of eus-bx vs.14/52 (26.9%) of p-bx had > 15 portal tracts.There were 6 (10.2%) eus-bx vs.1 (1.7%) p-bx related complication leading to a phone call (p = 0.061).Conclusions: eus-bx can safely performed and accurately predict liver fibrosis stage as the standard p-bx without being influenced by procedure-related factors.Complications: eight patients who underwent eus-bx and one patient who underwent p-bx had complications.There were 6 (10.2%) eus-bx versus 1 (1.7%) p-bx related complication leading to a post-procedure phone call (p = 0.061).Two (3.4%) eus-bx versus zero percutaneous liver biopsy complication led to an er visit (p = 0.496).Two (3.4%) eus-bx versus zero percutaneous liver biopsy complication led to a hospitalization for observation, (p = 0.496).One patient who underwent eus-bx had thrombocytopenia with platelet count of 101 × 109/l, stage 3 fibrosis, who called, was advised to present to the er, and was evaluated and sent home without hospitalization.The other 7 patients had no coagulopathy or thrombocytopenia.None of them were on anticoagulation or antiplatelet agents.This literature article requires 1 report.There is no report of any olympus device malfunction in any procedure described in this study.
Event or Problem Description
This literature article requires 3 reports: 1) (b)(6) -ultrasonic gastrovideoscope, model- gf-uc140p-al5, sn-unk.2) (b)(6) -- ultrasonic gastrovideoscope- model -gf-uc140p-al5- sn -unk (for gf-uc180p-al5 in the literature as a representative product with the same procode).3) (b)(6) - single use aspiration needle na-u200h na-u200h-8019, sn-unk.This medwatch is for patient identifier (b)(6).
Event or Problem Description
This medwatch is being submitted as a correction to f6 aware date.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 18041365
• Report Number: 2429304-2023-00342
• Device Sequence Number: 18161897
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023
• Report Date (Section F): 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NA-U200H-8019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/28/2023; 12/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ULTRASONIC GASTROVIDEOSCOPE GF-UC140P-AL5- SN -UNK.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown