MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H260Z

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

Patient Problem Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Health effect: the authors did not specify cause of death and also stated they were not disease-related.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following article: "demarcation of early esophageal squamous cell carcinoma during endoscopic submucosal dissection: a comparison study between lugol's iodine staining and narrow-band imaging."     this was a single-center, retrospective, cohort study was aimed to investigate and compare the effects on clinical outcomes between lugol¿s iodine staining (lis) and narrow-band imaging (nbi) are in the demarcation of early esophageal squamous cell carcinoma (eesccs) during endoscopic submucosal dissection and provide evidence to direct future clinical practice.A total of 172 consecutive patients were included and received two different margin determinations of the lesion, lis (n=109) and nbi (n=63).Data on clinical outcomes, adverse events, and follow-up information were collected for analysis.The study revealed that all patients underwent esd successfully with a mean procedure time of 52.5±38.1 minutes.The reported rates for en bloc and r0 resection was 100% and 89.5%, respectively.A total of 44 (25.6%) patients suffered adverse events, including 16 (9.3%) patients with in-hospital adverse events and 39 (22.7%) with esophageal stenosis.In conclusion, the study supported and recommended nbi as it was more convenient, lower efficient and without the risks raised by lugol¿s solution, also demonstrated efficacy in the demarcation of eesccs during esd, which showed a comparable accuracy and clinical outcomes with lis.    the adverse events reported (number of patients): [lugol¿s iodine group; n=109], total adverse events - (30), esophageal stenosis - (26), in-hospital adverse events - (12), fever (> 38°c) - (9), bleeding - (4), perforation - (2), mediastinal emphysema - (4), subcutaneous emphysema - (4), pleural effusion - (5), pneumothorax - (2), recurrence - (2).[nbi group; n=63], total adverse events - (14), esophageal stenosis - (13), in-hospital adverse events - (4), fever (> 38°c) - (2), bleeding - (2), perforation - (1), mediastinal emphysema - (1), subcutaneous emphysema - (1), pleural effusion - (1), pneumothorax - (1), esophageal fistula - (1), recurrence - (3), [follow-up], death - (2).The authors used multiple olympus devices and did not specify the device in association to the group of adverse events.Therefore, this article includes 6 reports: (b)(6) pw-5l adverse event from the lugol¿s iodine group and the nbi group.(b)(6) pw-5l deaths (n=2).(b)(6) gif-q260j adverse events from the lugol¿s iodine group and the nbi group.(b)(6) gif-q260j deaths (n=2).(b)(6) gif-h260z adverse event from the nbi group only.(b)(6) gif-h260z deaths (n=2).This report is for: (b)(6) gif-h260z deaths (n=2).

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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13758990
• MDR Text Key: 287169691
• Report Number: 8010047-2022-04377
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H260Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• 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