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

Model Number GIF-XQ260

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

Patient Problem Insufficient Information (4580)

Event Date 01/13/2021

Event Type  Death  

Event Description

Olympus reviewed the following literature titled "high-dose proton pump inhibitors are superior to standard-dose proton pump inhibitors in high-risk patients with bleeding ulcers and high-risk stigmata after endoscopic hemostasis." introduction: to define the best cutoff of the glasgow-blatchford score (gbs) for identifying high- and low-risk rebleeding patients with bleeding ulcers and high-risk stigmata after endoscopic hemostasis and compare the efficacy of high-dose and standard-dose intravenous proton pump inhibitors (hd-ivps and sd-ivps, respectively) in this patient population.Methods: we retrospectively reviewed the data of 346 patients with bleeding ulcers and high-risk stigmata who underwent endoscopic hemostasis between march 2014 and september 2018 in our center and were divided into an hd-ivp group and an sd-ivp group.Propensity score¿matching analysis was performed to control for selection bias and other potential confounders.Recurrent bleeding rates were calculated according to the gbs.Results: overall, 346 patients meeting the inclusion criteria were enrolled, with 89 patients in the sd-ivp group and 89 patients in the hd-ivp group after matching with all baseline characteristics balanced (p > 0.05).Gbs 58 was the best cutoff for identifying high-risk rebleeding patients (gbs ¿ 8) with a significant difference (p 5 0.015) in recurrence rate between the sd-ivp (17/61, 27.9%) and hd-ivp (7/65, 10.8%) groups and low-risk rebleeding patients (gbs < 8) with no difference (p 5 1) in recurrence rate between the sdivp (2/28, 7.1%) and hd-ivp (2/24, 8.3%) groups.Discussion: the best cutoff for identifying high-risk and low-risk rebleeding patients with bleeding ulcers and high risk stigmata after endoscopic hemostasis was gbs 5 8.Although hd-ivp is more effective than sdivp in high-risk patients, they are equally effective in low-risk patients.Type of adverse events/number of patients recurrent bleeding 209 patients surgery due to rebleeding 10 patients median hospital stay over 7 days 72 patients mortality/death 15 patients this literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) -xq260/death (b)(6) -xq260/ae (events other than death) 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

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.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: 17749316
• MDR Text Key: 323437491
• Report Number: 9610595-2023-13381
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-XQ260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• 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): Death