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

Model Number TJF-260V

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 07/18/2022

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature titled, "clinical benefit of early precut sphincintroterotomy for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography." objectives: a precut procedure is sometimes required for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ercp).However, it is unclear whether the biliary access rate has improved for early precut procedures compared to conventional techniques.This study aimed to identify the benefit of early precut sphincterotomy in cases showing difficult biliary access.Methods between april 2017 and august 2021, consecutive patients who underwent precutting for difficult biliary cannulation were retrospectively enrolled.The outcomes of early (=10 min from start of cannulation) and delayed (>10 min) precut groups were evaluated.All adverse events were defned according to cotton criteria.Results a total of 70 patients were enrolled in this study.The biliary cannulation rate for a frst ercp was significantly higher in the early compared to delayed precut group (95% vs.73.3%; p=0.015).A difference in overall cannulation rate between the two groups was not observed (97.5% vs.83.3%; p>0.05).Significantly higher rates of prophylactic pancreatic stents were described in the delayed compared to early precut group (36.7% vs.12.5%; p=0.009).Significant differences in the frequency of pancreatitis, bleeding, penetration, and perforation were not noted between the two groups.Overall, the success rate was statistically significant between the experienced and less experienced endoscopists (87.2% vs.63.9%; p=0.017).Conclusions early precutting within 10 min from the start of cannulation in ercp is safe and effective in cases with a difficult biliary cannulation, and can improve the biliary cannulation rate.Type of adverse events/number of patients: (early precut) post-ercp pancreatitis - 3 patients, bleeding - 2 patients, retroperitoneal penetration - 1 patient.(delayed precut) post-ercp pancreatitis - 3 patients, bleeding - 2 patients, retroperitoneal penetration - 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) /tjf-260v and (b)(6) /kd-v451m.This medwatch report is for patient identifier (b)(6).

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.

Event Description

This literature article requires 3 reports.The related patient identifiers are as follows: 1.(b)(6)/tjf-260v.2.(b)(6)/g-260-2545a.3.(b)(6)/kd-v451m.

• Brand Name: EVIS LUCERA 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: 16640708
• MDR Text Key: 312285853
• Report Number: 9610595-2023-05245
• 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: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/12/2023
• 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
• Treatment: NON-OLYMPUS: CANNULA; NON-OLYMPUS: ERBE
• Patient Outcome(s): Other; Required Intervention