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

Model Number JF-260V

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

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Pancreatitis (4481); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/26/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "fully covered self-expandable metallic stents versus plastic stents for preoperative biliary drainage in patients with pancreatic head cancer and the risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis".Literature summary objectives: optimal stents for preoperative biliary drainage (pbd) for patients with possible resectable pancreatic cancer remain controversial, and risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis (pep), followed by pbd, are unknown.In this study, the efficacy and safety of fully covered self-expandable metallic stents (fcsemss) and plastic stents (pss) were compared, and the risk factors for pep, followed by pbd, were investigated for patients with pancreatic cancer.Methods: consecutive patients with pancreatic cancer who underwent pbd between april 2005 and march 2022 were included.We retrospectively evaluated recurrent biliary obstruction, adverse events (aes), and postoperative complications for fcsems and ps groups and investigated the risk factors for pep.Results: a total of 105 patients were included.There were 20 patients in the fcsems group and 85 patients in the ps group.For the fcsems group, the rate of recurrent biliary obstruction (0% vs.25%, p = 0.03) was significantly lower.There was no difference in ae between the two groups.No significant differences were observed in the overall postoperative complications, but the volume of intraoperative bleeding was larger for the ps group than it was for the fcsems group (p < 0.001).From multivariate analysis, being female and lack of main pancreatic duct dilation were independent risk factors for pancreatitis (odds ratio, 5.68; p = 0.028; odds ratio, 4.91;p = 0.048).Early aes were not significantly different between the two groups (30% [6/20] vs.27% [23/85]; p = 0.79).The incidence of pep was 20% for the fcsems group.However, there was no significant difference in comparison to the ps group (20% [4/20] vs.8.2% [7/85]; p = 0.25).All patients improved after only conservative treatment.Late aes were similar for both groups (10% [2/20] vs.4.7% [4/85]; p = 0.36).Conclusions: fcsemss are thought to be preferable to pss for pbd due to their longer time to recurrent biliary obstruction.Being female and the lack of main pancreatic duct dilation were risk factors for pep.Type of adverse events/number of patients: event1: early post-ercp pancreatitis (mild:5/moderate:4/severe:2) - 11 patients.Event2: early acute cholangitis - 6 patients.Event3: early acute cholecystitis - 3 patients.Event4: bleeding - 1 patient.Event5: late acute pancreatitis - 1 patient.Event6: late acute cholangitis - 3 patients.Event7: late acute cholecystitis - 1 patient.Event8: liver abscess - 1 patient.Event9: intraoperative bleeding - number of patients unknown.This literature article requires 2 reports.The related patient identifiers are as follows: 1.(b)(6).2.(b)(6).This medwatch report is for (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

Health effect - clinical code 4581 is used to code for early and late acute cholecystitis.The suspect device has not been returned to olympus.Additional information has been requested but no information could be provided.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Manufacturer Narrative

This report is being supplemented to correct the health effect - impact code.

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 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 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: 17491418
• MDR Text Key: 320809100
• Report Number: 9610595-2023-11414
• 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,Followup
• Report Date: 09/12/2023

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: JF-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: 08/09/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/09/2023; 09/07/2023
• Supplement Dates FDA Received: 08/09/2023; 09/12/2023
• 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
• Patient Outcome(s): Required Intervention