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 Problem Pancreatitis (4481)

Event Date 10/12/2022

Event Type  Injury  

Manufacturer Narrative

The model description of tjf-260v and jf-260v was same.One of representative product was chosen for processing purposes.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, "endoscopic bridge-and-seal of bile leaks using a fully covered self-expandable metallic stent above the papilla".Background/aims: endoscopic management by endoscopic sphincterotomy with or without plastic stents or fully covered self-expandable metallic stents (fcsemss) is widely accepted as the current standard of care for postoperative bile leaks.Biliary stents are placed across the papilla, not above the papilla.We investigated the safety and effectiveness of the bridge-and-seal technique for bile leaks by the placement of fcsems above the papilla.Methods: this was a retrospective study of fcsems placement above the papilla for bile leaks between (b)(6) 2016 and (b)(6) 2021.Fcsems was placed above the papilla to bridge and seal the leak.The main outcome measures were the resolution of bile leaks and adverse events.Results: seven patients with postoperative bile leaks underwent fcsems above the papilla.The locations of bile leaks were 1 cystic duct remnant; 2 intrahepatic bile duct; 1 hepatic duct; 2 common bile duct and 1 anastomosis.The technical success rate of fcsems placement was 100%, and resolution of bile leaks was achieved in five patients (71.4%).All the adverse events were observed after fcsems removal; as follows: 1 moderate cholangitis; 2 mild post-ercp pancreatitis; and 1 mild remnant cholecystitis.Conclusions: fcsems placement above the papilla can be a treatment option for postoperative bile leaks.Type of adverse events/number of patients: patient of case 2 with pancreatitis, patient of case 3 with cholangitis and pancreatitis, patient of case 6 with remnant cholecystitis.This literature article requires 3 reports.The related patient identifiers are as follows: 1, (b)(6) (tjf-260v for case 2), 2, (b)(6) (tjf-260v for case 3), 3, (b)(6) (tjf-260v for case 6).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

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.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: 16287386
• MDR Text Key: 308706149
• Report Number: 9610595-2023-01712
• 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: 03/29/2023

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: 01/05/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/29/2023
• 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): Other
• Patient Age: 25 YR
• Patient Sex: Male