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

Model Number GIF-HQ290

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the (b)(6) that the duodenal mucosal injury and erosion occurred because the up angle was not up to standard during the diagnostic procedure using the subject device.The patient was suggested to take oral medication for treatment.Other information such as outcome of the patient was not provided.

Manufacturer Narrative

This supplemental report is being submitted to additional information.Olympus medical systems corp.(omsc) reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause could not be determined, but there was the possibility that the user applied the excessive bending and tensile stress to the subject device, it might cause the stretch of the angle wire, consequently the up angle might not be up to standard.The exact cause of the reported event could not be conclusively determined.

• Brand Name: EVIS LUCERA ELITE 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: 9443496
• MDR Text Key: 185501429
• Report Number: 8010047-2019-04214
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIF-HQ290
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other