MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ290

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

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

Event Date 05/14/2023

Event Type  Injury  

Manufacturer Narrative

The event date was reported as the publication date of the literature.The literature article is for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus reviewed the following literature titled "efficacy and safety of clearcut¿ knife h-type in endoscopic submucosal dissection for gastric neoplasms: a multicenter, randomized trial." literature summary: this randomized, controlled trial aimed to evaluate the efficacy and safety of the clearcut¿ knife h-type, which is an integrated needle-tipped and insulated-tipped (it) knife.A total of 98 patients (50 in the h-knife group and 48 in the it-knife group) were analyzed.The median total procedure time was 11.9 minutes (range, 4.4¿47.2 minutes) in the h-knife group and 12.7 minutes (range, 5.2¿137.7 minutes) in the it-knife group (p=0.209).The complete resection rates in the h-knife and it-knife groups were 97.9% and 95.8%, respectively (p>0.999).The curative resection rate was lower in the h-knife group than in the it-knife group (89.4% vs.93.8%, p=0.486).The overall adverse event rates were not significantly different between the 2 groups (p=0.431).The newly developed hybrid device, the clearcut¿ knife h-type, had comparable efficacy to the conventional it knife for gastric esd.Type of adverse events/number of patients gif-q260j, gif-hq290: *early delayed bleeding(4) , *microperforation(2) , itknife2, dual knife: *early delayed bleeding(4) microperforation was defined as minimal free air on chest radiography without symptoms or signs of peritonitis.Microperforation occurred in 2 patients (4.0%) in the h-knife group.The patients with microperforations were treated conservatively without additional interventions.Early delayed bleeding was confirmed in 4 patients in the it-knife group (8.3%) and required additional hemostasis and an extension to the hospitalization period.There is no report of any olympus device malfunction in any procedure described in this study.This literature requires 4 reports.The related patient identifiers are as follows: (b)(6) :gif-q260j, (b)(6) :gif-hq290, (b)(6) :kd-611l & (b)(6) :kd-650l.This report is for (b)(6).

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 ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 17843352
• MDR Text Key: 324583536
• Report Number: 9610595-2023-14310
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-HQ290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• 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): Hospitalization; Required Intervention