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

Model Number GF-UCT180

Device Problems Peeled/Delaminated (1454); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, probe unit pink rubber cut and lg cover glue peeling were noted.In addition, bending section cover chip and control knob leak were observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility reported to olympus that the evis exera ii ultrasound gastrovideoscope has a minor leak.The event occurred during reprocessing, prior to an unknown diagnostic procedure.During a standard service inspection of the customer returned device, probe unit pink rubber cut and lg cover glue peeling were noted.This report is to capture the reportable malfunction found at inspection.There was no patient involvement, no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, external forces may have contributed to the issue.However, the definitive root cause of the reported event could not be determined.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: 12965188
• MDR Text Key: 285982166
• Report Number: 8010047-2021-15781
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341809
• UDI-Public: 04953170341809
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 11/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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