MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA DUODENOVIDEOSCOPE

Model Number TJF-145

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

Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930)

Event Date 12/07/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "acute kidney injury after endoscopic retrograde cholangiopancreatography¿a hospital-based prospective observational study".Background: endoscopic retrograde cholangiopancreatography (ercp) represents a major pivotal point in gastrointestinal endoscopy.Little is known about acute kidney injury (aki) post-ercp.This study analyses the incidence, risk factors, and prognosis of post-ercp aki.Methods: a total of 396 patients were prospectively studied.Aki was defined by an increase in serum creatinine (scr) = 0.3 mg/dl or by an increase in scr = 50% in the first 48 h post-ercp.Logistic regression analysis was used to identify the predictors of aki and in-hospital mortality.A two-tailed p value < 0.05 was considered significant.Results: one hundred and three patients (26%) developed post-ercp aki.Estimated glomerular filtration rate (adjusted odds ratio (aor) = 0.95, 95% confidence interval (ci): 0.94¿0.96, p < 0.001), nonrenal charlson comorbidity index (aor = 1.19, 95% ci: 1.05¿1.35, p = 0.006), choledocholithiasis (aor = 4.05, 95% ci: 1.98¿8.29, p < 0.001), and bilirubin (aor = 1.1, 95% ci: 1.05¿1.15, p < 0.001) were associated with post-ercp aki.Post-ercp aki was associated with longer hospital stay (p < 0.001) and with increased in-hospital mortality (7.76% versus 0.36%, p < 0.001).Moderate-to-severe (stage 2 and 3) aki was independently associated with in-hospital mortality (aor = 6.43, 95% ci: 1.48¿27.88, p < 0.013).Conclusions: post-ercp aki represented an important complication associated with longer hospital stay.Moderate-to-severe post-ercp aki was an independent risk factor for in-hospital mortality.Type of adverse events/number of patients pancreatitis - 14 patients.Bleeding - 2 patients.Perforation - 2 patients.Death - 9 patients.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6): adverse events.(b)(6): deaths.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.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article doi: 10.3390/biomedicines10123166 provided for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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 event 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.This supplemental report includes a correction to e4 to provide information inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16108542
• MDR Text Key: 306780656
• Report Number: 9610595-2023-00246
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K954451
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2023
• 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): Death