MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the olympus service center.The evaluation confirmed the ultrasound image has multiple broken elements.The forceps cover adhesive, objective lens adhesive and light guide lens adhesive at the distal end are peeling off.The electronic connector was found leaking.There are minor buckles on the elevator plug is loose, the scope connector is loose, el connector missing lockpin and the control knob has play/loose.The scope was last repaired on march 26, 2019 due to a leak in the channel.The scope was repaired to standard specifications and returned to the customer.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The user facility reported that during an unspecified event, the evis exera ii ultrasound gastro-videoscope had a "bad picture".No patient injury or harm was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the forceps cover glue peeling was likely caused by an external force was applied to the distal end leading to peeling of the glue.Additionally, the amount of use and age of the device (over 5 years) is likely to lead to deterioration.This issue is addressed in the instructions for use (ifu) and can be detected: "inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.".Per the legal manufacturer, the other device defects included in the initial mdr have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11228562
• MDR Text Key: 241236282
• Report Number: 8010047-2021-01880
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170355479
• UDI-Public: 04953170355479
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1