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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection and testing, damage was observed at the acoustic lens at the distal end.There was a gap at the acoustic lens adhesive, which could allow stains to enter the device.Additionally, the distal end rubber cover adhesive was defective, the el connector mouthpiece pin was detached, connecting tube was kinked, air/water and suction cylinder nut was damaged, acoustic lens and image guide cover lens are damaged, scope cover and scope body are scratched, and angulation wire has play.The user¿s complaint leaking at the distal end rubber cover adhesive was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

The device was returned for repair for the issue of leaking at the distal end rubber cover adhesive observed during reprocessing during the disinfection cycle.There is no harm reported to any patient.The procedure previous to the reprocessing was completed successfully.At the time of evaluation of the returned device, damage was observed at the acoustic lens at the distal end.There was a gap at the acoustic lens adhesive, which could allow stains to enter the device.This medwatch is being submitted for the reportable issue of the gap of the acoustic lens adhesive observed during device evaluation.

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 found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, the cause of the damaged probe unit acoustic lens likely occurred due to stress and/or handling the device.The specific root cause could not be determined at this time.The following information is stated in the instructions for use: "3.2 inspection of the endoscope.5.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, peeling, scratches, holes, sagging, transformation, bends, adhesion of foreign body, detached, parts, protruding objects, or any other irregularities." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be (b)(6) 2021.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13020368
• MDR Text Key: 286838048
• Report Number: 8010047-2021-16265
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: LG
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 02/19/2022; 11/08/2022
• Supplement Dates FDA Received: 03/10/2022; 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1