MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290T

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Type  Injury  

Event Description

Olympus reviewed the following literature article: "original article efficacy of partial injection underwater endoscopic mucosal resection for superficial duodenal epithelial tumor: propensity score-matched study (with video)."     literature summary background and aim: underwater endoscopic mucosal resection (uemr) has been reported as effective endoscopic treatment for superficial duodenal epithelial tumors (sdets).However, it has been reported that a notable problem of uemr for sdets is that en bloc resection rate is relatively low.Therefore, we proposed a novel technique to improve en bloc resection rate: uemr combining partial submucosal injection (pi-uemr).The aim of this study is to evaluate efficacy and safety of pi-uemr for sdets by comparing to uemr.Methods: this is a retrospective observational study in a single center.The patients who underwent uemr or pi-uemr from june 2010 to august 2020 were included in this study.Eligible patients were selected from included patients in a 1:1 ratio using propensity score matching.The clinical outcomes of endoscopic resection (procedure time, en bloc resection rate, complication rate [immediate perforation, delayed bleeding, delayed perforation]), and histopathologicaldiagnosis (adenoma/cancer) were compared between each group.Results: two hundred and twenty-eight patients were included in this study.Of included patients, 47 patients were selected in each group by propensity score matching.There were no statistical differences in procedure time (11 + 1.2 min vs.9 ± 1.2 min, p = 0.30), complication rate (immediate perforation [0% vs.2%, p = 0.12], delayed bleeding [0% vs.2%, p = 0.12], and no delayed perforation) and histopathological diagnosis (adenoma; 100% vs.96%, p = 0.14) in each group.However, en bloc resection rate of pi-uemr was significantly higher than uemr (96% vs.83%, p < 0.05).Conclusion: partial submucosal injection uemr might be superior procedure for en bloc resection in sdets compare to uemr.The authors stated the intraoperative perforation was closed with endoscopy clips.The delayed bleeding was controlled by urgent endoscopy without blood transfusion.The authors used 3 different olympus devices for the following events: type of adverse events/number of patients: intraoperation perforation n=1, delayed bleeding n=1.  this article includes 3 reports: patient identifier (b)(6), 15 or 20mm, patient identifier (b)(6), patient identifier (b)(6).This report is 3 of 3 for patient identifier (b)(6).

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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.Correction b1: after receiving additional information from the author, the adverse events reported in the literature article have been determined not to be serious injuries.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

Event Description

Additional information received from the author: in the opinion of the author, the olympus device did not cause or contribute to the adverse events reported.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 14375506
• MDR Text Key: 293370156
• Report Number: 8010047-2022-08138
• Device Sequence Number: 1
• Product Code: FDS
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H290T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• 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: SD-210L-10, 15 OR 20MM, LOT UNKNOWN
• Patient Outcome(s): Required Intervention; Other