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 11/18/2021

Event Type  malfunction  

Event Description

The service center was informed that a customer evis exera ii ultrasound gastrovideoscope's "elevator water channel has lots of bubbles when leaking tested" during reprocessing.During inspection and testing, the technician found an adhesive malfunction as the adhesive at the distal end forceps cover was peeled or crack off.The customer confirmed there was no reports of device fragment falling into a patient or any injury or harm.

Manufacturer Narrative

The technician found an adhesive malfunction as the adhesive at the distal end forceps cover was peeled or crack off.The customer's reported issue was confirmed as the was leaking from the elevator channel inlet; fluid invasion and corrosion found inside the body control unit.Additionally, the bending section cover glue is chipped.A review of the repair history shows no previous repair records.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

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 1 year 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.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: 13027581
• MDR Text Key: 284196352
• Report Number: 8010047-2021-16343
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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: 11/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2020
• 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