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

Model Number GF-UCT180

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, it was noted that the ultrasound image contain multiple broken elements.The light guide lens cover at the distal edge had peeling glue.The distal sheath and the distal sheath's glue were non-olympus parts.Additionally, the switch button was misaligned.Upon completion of the investigation, or if additional information should become available, a supplemental report will be submitted.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

As reported, during preparation for use, the evis exera ii ultrasound gastrovideoscope was displaying a compromised image.According to the initial reporter, the device had broken crystals.No patient consequences were reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿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.¿ a definitive root cause could not be determined.But investigation suspects that some external force was applied to the distal end, leading to the peeling of the glue at the tip.In addition, they note that the device was manufactured on 16nov2015, and it is possible that it was affected by aging deterioration.Olympus will continue to monitor the field performance of this device.

• 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: 11142812
• MDR Text Key: 234250179
• Report Number: 8010047-2021-01141
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1