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 Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

At the olympus service center, the customer¿s issue was not confirmed.The scope passed the leak test.Other issues were found.The bending section cover glue was cracked.The forceps cover glue was peeling.The scope connector was loose, and the customer label had corrosion.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported by the customer, the evis exera ii ultrasound gastrovideoscope had a leak at the distal tip.No patient harm reported.During the evaluation of the device, it was noted the forceps cover glue was peeling.This report is to capture the reportable malfunction of peeling forceps cover glue noted at estimation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 5 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the forceps cover glue peeling could not be identified.However, it is possible the cause was related to some kind of external force that was applied to the relevant part.Per the instructions for use: -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.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12932860
• MDR Text Key: 285924702
• Report Number: 8010047-2021-15575
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

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: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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