MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number	TGF-UC180J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Biliary Cirrhosis (1736); Thrombocytopenia (4431)
Date of Event	03/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This report has been submitted by the importer under mdr report number 2429304 - 2023 ¿ 00011.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled, "endoscopic ultrasound-guided porto-systemic pressure gradient measurement correlates with histological hepatic fibrosis".Background and aims: endoscopic ultrasound is a novel diagnostic approach to chronic liver diseases (clds), and eus-guided porto-systemic pressure gradient measurement (eus-ppg) is an important expansion with a well-developed technique.However, the clinical value and applicability of eus-ppg measurement in predicting histologically advanced hepatic fibrosis remain unknown.Methods: this was a single-center retrospective study on patients with various clds undergoing eus-ppg and eus-guided liver biopsy (eus-bx) to assess if eus-ppg measurements correlate with histological fibrosis stage and various surrogate markers for severity of clds and its safety.Cases with eus-ppg were identified at the university of california irvine, a tertiary endoscopy center, between january 2014 and march 2020.Results: in 64 patients, the mean age was 57.5; 40 (62.5%), males; mean child-turcotte-pugh (ctp) and model for end-stage liver disease (meld) scores, 5.9 and 10.4, respectively.The procedure success rate was 100%.Twenty-nine (45.3%) had eus-ppg=5 mmhg that was associated with clinical cirrhosis (p<0.0001), clinical portal hypertension (p=0.002), hepatic decompensation (p=0.013), meld-na>10 (p=0.036), plts=120×109/l (p=0.001), inr=1.05 (p=0.007), presence of ev, gv, or phg (p0.0001), biopsy-proven fibrosis stage=3 (p=0.002), apri>2 (p=0.001), and fib-43.25 (p=0.001).Multivariable analysis confirmed that eus-ppg=5 mmhg was significantly associated with liver biopsy-proven fibrosis stage=3 (lr 27.0, 95% ci=1.653¿360.597, p=0.004), independent of c-cirrhosis, c-phtn, thrombocytopenia, splenomegaly, and apri score>2, and fib-4 score>3.25.There were no serious complications related to eus-ppg procedures.Conclusions: eus-ppg measurements provide excellent correlation with histological hepatic fibrosis stage and various clinical, laboratory, endoscopic and imaging variables indicative of advanced liver disease without serious adverse events.Type of adverse events/number of patients: cirrhosis, thrombocytopenia.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6) /gf-uc140p-al5.(b)(6) /gf-uc180j.(b)(6) /na-u200h-8019s.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16212254
• Report Number: 3002808148-2023-00597
• Device Sequence Number: 4341365
• Product Code: ODG
• UDI-Device Identifier: 04953170328480
• UDI-Public: 04953170328480
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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: TGF-UC180J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown