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

Model Number GIF-Q260J

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

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Bowel Perforation (2668)

Event Date 05/24/2023

Event Type  Injury  

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.

Event Description

Olympus reviewed the following literature titled "usefulness of the s-o clip for duodenal endoscopic submucosal dissection: a propensity score-matched study." this retrospective study evaluated the efficacy and safety of duodenal endoscopic submucosal dissection (esd) using an s-o clip for superficial non-ampullary duodenal tumors (snadets).The retrospective study was patients who underwent esd for snadets between (b)(6) 2021.Propensity score matching analysis was used to compare patients who underwent duodenal esd with the s-o clip (s-o group) and those who underwent conventional esd (control group).Sixty patients with snadets who were treated with esd were enrolled.After propensity score matching, 16 pairs were created: 43 and 17 in the s-o and control groups, respectively.All esd procedures were performed using a single-channel endoscope (gif-h260j) with a transparent hood (d-201-11804) and hook knife (kd-625lr).S-o group: 43 patients.Delayed bleeding: 2 patients.Control group: 17 patients.Intraoperative perforation: 4 patients.Delayed perforation: 1 patient.In case of delayed complications, computed tomography and blood tests were performed.Delayed bleeding treated with endoscopic hemostasis after esd.Most of the cases of intraoperative perforation were successfully managed with conservative treatment alone.However, some cases required conversion to surgery.Another patient in the study developed a retroperitoneal abscess due to an intraoperative perforation and was hospitalized for 67 days.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): gif-q260j.(b)(6): kd-625lr.(b)(6): d-201-11804.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 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: 18634420
• MDR Text Key: 334492538
• Report Number: 9610595-2024-02345
• 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,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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: GIF-Q260J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/15/2024
• 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: D-201-11804; KD-625LR
• Patient Outcome(s): Hospitalization; Required Intervention