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

Model Number TJF-240

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

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Since there is no olympus device called "tjf 240 v", the "tjf-240" was selected as a representative product.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 "risk factors for perforation during endoscopic papillary large balloon dilation and bile duct stone removal." this retrospective study aimed to investigate the risk factors for perforation during eplbd+ stone removal.A total of 310 patients with a median age of 79 years were included.Perforation occurred in five patients (1.6%).Multivariate analysis indicated that no surrounding pancreas (half or less of the circumference of the intrapancreatic bile duct was surrounded by the pancreatic parenchyma) was a significant risk factor (perforation rate: 8.3%, p=.011, odds ratio: 12.7 [95% confidence interval: 1.8¿90.5]).No significant difference was found between the over-dilation and non-over-dilation groups regarding the occurrence of pancreatitis, bleeding, and cholangitis.The perforation rate in patients with no surrounding pancreas + overdilation was 16.7% (2/12).Patients with perforation underwent conservative therapy, which improved their conditions.This study concluded that the eplbd + stone removal should be avoided in patients with no surrounding pancreas.Overdilation is not a risk factor for adverse procedural events; however, it should be limited in patients with surrounding pancreas.Type of adverse events/number of patients.Perforation -5 patients.Overdilation group: pancreatitis - 4 patients, bleeding - 6 patients, cholangitis - 1 patient.Non-overdilation group: pancreatitis - 3 patients, bleeding - 3 patients, cholangitis - 1 patient.The authors used many olympus devices and did not specify the olympus device used in relation to the adverse events experienced by the patients.Therefore, the olympus devices will be reported as follows: (b)(6) : evis lucera duodenovideoscope jf-260v or tjf-260v.(b)(6): evis duodenovideoscope tjf-240.(b)(6) : stonemasterv single use balloon dilator v (with knife) bd-vc431q-1840-25.(b)(6) : gastrointestinal videoscope gif-1t240 evis.(b)(6) : evis lucera small intestinal videoscope sif-q260, sif-y0004, sif-y0015.(b)(6) : evis lucera elite small intestinal videoscope sif-h290s, sif-y0004, sif-y0015.This medwatch report is for patient identifier (b)(6).The perforations were determined to be not reportable as they were not caused by or contributed to the olympus device, per the author of the article.There is no report of any olympus device malfunction in any procedure described in this study.

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 information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15127003
• MDR Text Key: 296843620
• Report Number: 9610595-2022-00404
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• 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
• Treatment: BD-VC431Q-1840-25, SN UNKNOWN; CRE BALLOON DILATOR (BOSTON SCIENTIFIC CORP.); GIF-1T240, SN UNKNOWN; JF-260V, TJF-260V, SN UNKNOWN; MECHANICAL OR ELECTROHYDRAULIC LITHOTRIPSY; REN BILIARY BALLOON (KANEKA MEDIX CORP.); SIF-Q260, SIF-H290S, SIF-Y0004, SIF-Y0015
• Patient Outcome(s): Other