MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. 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 Date 02/02/2022

Event Type  Injury  

Manufacturer Narrative

Name of the user facility: (b)(6).The serial number of the device was not provided in the article; therefore, it is unknown if the device has already been returned to olympus for evaluation or not.Olympus will be contacting the author of the literature to obtain more information regarding the reported events.The cause of the patients¿ outcome cannot be conclusively determined at this time.If new and relevant information is obtained later, this report will be supplemented accordingly.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "efficacy of the pocket-creation method with a traction device in endoscopic submucosal dissection for residual or recurrent colorectal lesions".Literature summary: this study aimed to compare the efficacy of the pocket-creation method (pcm) with a traction device (td) with that of conventional esd for residual or recurrent colorectal lesions in 72 patients.The primary endpoints were en bloc resection and r0 resection rates.En bloc resection was feasible in all cases with pcm with td, but failed in 22% of cases of conventional esd.The r0 resection rates for pcm with td and conventional esd were 97% and 66%, respectively.Dissection was significantly faster in the pcm with td group (13.0 vs.7.9 mm2/min).This study concludes that the pcm with td is an effective method for treating residual or recurrent colorectal lesions after incomplete resection.Type of adverse events/number of patients: control group, perforation - 1 patient, post-procedural bleeding - 1 patient, pcm with td group, perforation - 1 patient, post-procedural bleeding - 1 patient.Since the literature described "pcf-q260j", we selected "pcf-q260ji" as a representative product.The product was unknown but a representative product was chosen for processing purposes.Since the literature described "pcf-h290t", we selected "pcf-h290ti" as a representative product.The product was unknown but a representative product was chosen for processing purposes.The following are the related complaints.This is 6 of 8 reports.1.(b)(6) (d-201-11804).2.(b)(6) (single use electrosurgical knife).3.(b)(6) (fd-411qr).4.(b)(6) (hx-610-090s).5.(b)(6) (gif-q260j).6.(b)(6) (gif-h290t).7.(b)(6) (pcf-q260ji).8.(b)(6) (pcf-h290ti).The literature stated that in terms of adverse events, there was no significant difference between groups with respect to perforation or postoperative bleeding rates.Both cases of perforation were minor that occurred during esd.In both cases, the perforation sites were completely closed with endo-clips.The cases were conservatively managed with antibiotics, and none of the patients required emergency surgery.

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.This supplemental report includes a correction to d8 and g2.Information added to these fields that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the authoring physician who stated that the reported adverse event reported in the literature is not caused by any of the olympus devices, as there was no reported device malfunction.In addition, based on the clinical/medical evaluation and risk assessment, it is presumed that the reported event is an accident, or a complication associated with a surgical procedure using the subject 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: 16031178
• MDR Text Key: 306077260
• Report Number: 9610595-2022-05937
• 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: Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 03/16/2023
• 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
• Treatment: D-201-11804, LOT NUMBER IS UNKNOWN.; FD-411QR- HEMOSTATIC FORCEPS, LOT NUMBER UNKNOWN.; HX-610-090S, LOT NUMBER IS UNKNOWN.; KD-650Q-DUAL KNIFE, LOT NUMBER UNKNOWN.; KD-655Q- DUAL KNIFE, LOT NUMBER UNKNOWN.; VIO 300D- ERBE ELECTROCAUTERY DEVICE.
• Patient Outcome(s): Required Intervention