MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE DISTAL ATTACHMENT; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number UNKNOWN

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.This complaint will capture 3 of 3 patients in the esd group for translucent cap, unknown model number d-201.The device was returned for evaluation.The device history could not be performed as the article did not specify the model or lot number of the referenced translucent cap.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined.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: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10044656
• MDR Text Key: 190596777
• Report Number: 2951238-2020-00440
• Device Sequence Number: 1
• Product Code: FDS
• 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: 04/13/2020,05/11/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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
• Date Report to Manufacturer: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention