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

Model Number GF-UCT180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Hypoxia (1918); Pancreatitis (4481); Muscle Hypotonia (4531); Unspecified Tissue Injury (4559)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "factors affecting the learning curve in the endoscopic ultrasound-guided sampling of solid pancreatic lesions: a prospective study" literature summary background/aims: endosonography is associated with a long learning curve.We aimed to assess variables that may influence the diagnostic outcomes in endoscopic ultrasound-guided fine-needle aspiration/biopsy (eus-fna/b) of solid pancreatic tumors regarding the level of endoscopists' experience.Methods: consecutive patients undergoing eus-guided puncture of solid pancreatic tumors (eight endosonographers, including six trainees) were prospectively enrolled.An experienced endosonographer was defined as having performed at least 250 eus examinations, including 75 fna/bs.The final diagnosis was determined by cytopathology, histopathology, or clinical follow-up.Results: in total, 283 eus-fna/bs of solid pancreatic tumors (75.6% malignant) in 239 patients (median age 69 years, 57.6% males) were enrolled.Trainees performed 149/283 (52.7%) of the interventions.Accuracy and sensitivity for detecting malignancy were significantly higher in the expert group than in the trainee group (85.8% vs 73.2%, p=0.01 and 82.5% vs 68.4%, p=0.02).Solid lesions evaluated by an expert using fnb needles showed the best odds for a correct diagnosis (odds ratio, 3.07; 95% confidence interval, 1.15 to 8.23; p=0.02).More experienced endoscopists achieved better accuracy in sampling via the transduodenal approach (86.7% vs 68.5%, p<0.001), in the sampling of malignant lesions (82.5 vs 68.4, p=0.02), and in the sampling of lesions located in the pancreatic head (86.1 vs 69.1, p=0.02).In cases involving these factors, we observed a moderate improvement in the diagnostic accuracy after 40 attempts.Conclusions: transduodenal approach, pancreatic head lesions, and malignancy were recognized as the most important clinical factors affecting the learning curve in eus-fna/b of solid pancreatic lesions.Type of adverse events/number of patients event1: procedure-related adverse events (6 cases, including two major bleedings) - both were immediately stopped by endoscopic intervention.Event2: minor bleeding (32 cases) - overall, there was no need for a blood transfusion, and none of the patients presented as hemodynamically unstable.Event3: pancreatitis (1 case) - treated conservatively.Event4: severe abdominal pain (1 case) - treated conservatively.Event5: mucosal injury at the gastroesophageal junction (1 case) - treated conservatively.Event6: sedation-related complications (7 cases) - five with prolonged hypoxia and two with hypotonia no intensive care admission was needed.Two complaints are required for this event, as there are two devices involved: c23517452 is for the evis exera ii ultrasound gastrovideoscope (all events).C23517453 is for the single use aspiration needle (all events).This report is for c23517452.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was 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 relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18301123
• MDR Text Key: 330169158
• Report Number: 3002808148-2023-14030
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention