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 10/14/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "usefulness of intraductal placement of a dumbbell-shaped fully covered self-expandable metal stent for post-cholecystectomy bile leaks".¿literature summary¿ background and aims: in the treatment of post-cholecystectomy bile leaks, endoscopic naso-biliary drainage (enbd) or biliary stenting using plastic stents is the standard of care.Fully covered self-expandable metal stent (fcsems) placement across the sphincter of oddi is considered a salvage therapy for refractory cases, but pancreatitis and migration are the major concerns.Intraductal placement of a dumbbell-shaped fcsems (d-sems) could avoid these drawbacks of fcmsess.In this retrospective study, we investigated the usefulness of intraductal placement of the d-sems for post-cholecystectomy bile leaks.Methods: six patients who underwent intraductal placement of the d-sems for post-cholecystectomy bile leaks were enrolled.This method was performed as initial treatment in three patients and as salvage treatment in three enbd refractory cases.Results: technical and clinical successes were obtained in 6 (100%) patients and 5 (83%) patients, respectively.One clinically unsuccessful patient required laparoscopic peritoneal lavage.The early adverse event was one case of mild pancreatitis (17%).The median duration of the d-sems indwelling was 61 days (42¿606 days) with no migration cases, all of which were successfully removed.The median follow-up after index ercp was 761 (range: 161¿1392) days with no cases of recurrent bile leaks.Conclusions: intraductal placement of the d-sems for post-cholecystectomy bile leaks might be safe and effective even in refractory cases.¿type of adverse events/number of patients¿ 1) early adverse event- pancreatitis (1) 2) late adverse event: stent -stone completx (1) this complaint is related to the linked patient identifier (b)(6).

Manufacturer Narrative

Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18692361
• MDR Text Key: 335189838
• Report Number: 9610595-2024-02981
• 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
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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
• Date Manufacturer Received: 01/18/2024
• 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: DUODENOVIDEOSCOPE, TJF-Q290V,
• Patient Outcome(s): Other