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

Model Number GIF-1TH190

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

Patient Problem Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

[endoscopic submucosal dissection.].

Event Description

Olympus medical systems corp.(omsc) received a journal article titled "endoscopic submucosal dissection is associated with less pathologic uncertainty than endoscopic mucosal resection in diagnosing and staging barrett¿s-related neoplasia." the documented study reviewed the difference in the removal of esophageal lesions via endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd), pathological specimen and clinical decision-making and the secondary evaluation of the effect on the outcome of the patient.During the study, it was reported that delayed esophageal strictures developed in four of the patients, one in the emr group and three in the esd group.In all four patients, they required endoscopic dilatation.There was no additional information available.As no serial numbers were provided for the scopes used in the study olympus is unable to determine if the devices were returned for evaluation or perform a device history record review.This complaint will capture patient 2 of 3 in the esd group using scope model number gif-ith190.Podboy, a., kolahi, s., friedland, s.& louie, c.(2020).Endoscopic submucosal dissection is associated with less pathologic uncertainty than endoscopic mucosal resection in diagnosing and staging barrett¿s-related neoplasia.Digestive endoscopy, 32, 346-354.Https://doi.Org/10.1111/den.13487.

• Brand Name: EVIS EXERA III 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
• MDR Report Key: 10042820
• MDR Text Key: 190498653
• Report Number: 2951238-2020-00439
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention