MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

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

Patient Problems Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 03/06/2021

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "long slimmer metal stent is feasible and effective for endoscopic dual stent-by-stent placement in malignant hilar biliary stricture".Literature summary: the aim of this study was to evaluate the feasibility, efficacy, and safety of the new metal stent for palliative treatment of malignant hilar biliary strictures (mhbs).The technical success rate was 100%, with a mean procedure time of 43.7 ± 11.5 min.The clinical success was achieved in 44 patients (97.8%).Early adverse events included mild acute pancreatitis (n = 2) and cholangitis (n = 3).Later cholangitis occurred in 14 of the 45 patients due to stent occlusions.The median stent patency was 260 days (95% ci 228.3¿291.7).Stent malfunctions occurred in 23 of the 45 patients, and 15 of them received bilateral endoscopic plastic stents placements.The technical success for the re-intervention was 100% with the mean procedure time of 24.3 ± 4.5 min.The median overall survival of the whole group was 229 days (95% ci 171.2¿286.8).The long slimmer metal stent for bilateral endoscopic stent-by-stent placement proved to be safe, feasible, and effective for mhbs and facilitates endoscopic re-intervention as well type of adverse events/number of patients: mild acute pancreatitis - (2).Cholangitis - (3).Later cholangitis - (14).All pep cases were graded as mild and recovered in 1¿3 days after conservative management.The patients with acute cholangitis were treated with antibiotics without the need of additional endoscopic or percutaneous interventions.During a median follow-up period of 245.3 (46¿638) days, later cholangitis occurred in 14 of the 45 patients.Stent malfunctions occurred in 23 of the 45 patients.Six patients underwent ptbd in other hospitals.Two patients died of cholangitis.The remaining 15 of the 23 patients underwent endoscopic re-intervention in our center.The causes of stent malfunction included overgrowth (2/15), ingrowth (9/15), and sludge (4/15).Bilateral plastic stents were successfully inserted into both sides through the bilateral metal stents¿ lumen.This article includes 3 reports: patient identifier (b)(6): tjf-240.Patient identifier (b)(6): tjf-260v.Patient identifier (b)(6): kd-vc411q-0320.This report is 2 of 3 for patient identifier (b)(6): tjf-260v.

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

Additional information was received from the author: there was no malfunction of the olympus device in any procedure described in this study.In the opinion of the author, the olympus device did not cause or contribute to the reported adverse events.

Manufacturer Narrative

This report is being supplemented to provide a correction as additional information was received from the author.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in h6 and h10.The device history record was unable to be reviewed for this device since the serial 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14548295
• MDR Text Key: 292979126
• Report Number: 8010047-2022-09115
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

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: 05/06/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/13/2022; 06/13/2022
• Supplement Dates FDA Received: 07/07/2022; 07/07/2022
• 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: LOT UNKNOWN KD-VC411Q-0320.
• Patient Outcome(s): Other