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 Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Multiple Organ Failure (3261); Cancer (3262); Liver Failure (4492)

Event Date 04/26/2023

Event Type  Death  

Event Description

Olympus reviewed the following literature titled "clinical outcomes of clip-assisted endoscopic cyanoacrylate injection versus conventional endoscopic cyanoacrylate injection in treating gastric varices with a gastrorenal shunt".Background and study aims: the optimal treatment for gastric varices (gvs) is a topic that remains definite for this study.This study compared the clinical outcomes of clip-assisted endoscopic cyanoacrylate injection (clip-eci) to conventional endoscopic cyanoacrylate injection (con-eci) for the treatment of gvs with a gastrorenal shunt.Patients and methods: data were collected retrospectively in five medical centers from 2015 to 2020.The patients were treated with con-eci (n = 126) or clip-eci (n = 148).Clinical characteristics and procedural outcomes were compared.Patients were followed until death, liver transplantation or 6 months after the treatment.The primary outcome was rebleeding, and the secondary outcome was survival.Results: there were no significant differences in age, sex, etiology, shunt diameter and child-pugh classification between the two groups.Fewer gvs obliteration sessions were required in the clip-eci group than in the con-eci group (p = 0.015).The cumulative 6-month rebleeding-free rates were 88.6% in the clip-eci group and 73.7% in the con-eci group (p = 0.002).The cumulative 6-month survival rates were 97.1% in the clip-eci group and 94.8% in the con-eci group (p = 0.378).Conclusions: compared with con-eci, clip-eci appears more effective for the treatment of gvs with a gastrorenal shunt, which required less sessions and achieved a higher 6-month rebleeding-free rate.Type of adverse events/number of patients: event1: complication (45 cases) (includes the following events) - ectopic embolism (2 cases) - fever (34 cases) - abdominal pain (3 cases) - nausea (2 cases) - chest pain (2 cases) - epigastric discomfort (1 case) - suspected anaphylaxis (1 case).Event2: rebleeding (46 cases) (causes are as follows) - varices (14 cases) - postinjection ulcers (19 cases) - portal hypertensive gastropathy (4 cases) - unknown (9 cases).Event3: death (10 cases) (causes are as follows) - rebleeding (4 cases) - hepatic failure (2 cases) - hepatic cancer (2 cases) - multiple organ dysfunction syndrome (1 cases) - acute pulmonary embolism (1 cases).This article requires 2 reports: the related patient identifiers are as follows: (b)(6) gif-q260j evis lucera gastrointestinal videoscope (model gif-q260j) - captures event 1 and event 2 (b)(6) gif-q260j evis lucera gastrointestinal videoscope (model gif-q260j) - captures event 3 (death).This medwatch is for patient identifier (b)(6) (event 3 death).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

E1 establishment name: (b)(6) hospital.The suspect device has not been returned to olympus for evaluation.The literature article is attached for additional information.Doi.Org/10.1080/00365521.2023.2204388 provided for additional information.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

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 events 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: 18315648
• MDR Text Key: 330326126
• Report Number: 9610595-2023-19422
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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
• Date Manufacturer Received: 12/27/2023
• 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: INJECTION NEEDLES, METAL CLIPS; NEEDLE CATHETER, TISSUE ADHESIVES
• Patient Outcome(s): Death