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  

Event Description

A user facility returned the olympus, model gf-uct180, evis exera ii ultrasound gastrovideoscope to olympus for repair due to a report of "leakage from the controls." upon inspection and testing of the returned device, it was noted that a gap of adhesive was present on the distal end.This report is submitted due to the malfunction of a gap of adhesive on the distal end.As this was found during in-house service, there was no patient involvement.

Manufacturer Narrative

The device was evaluated by olympus and it was determined a gap of adhesive was present on the distal end due to peeling or a crack, likely attributable to a shock caused by dropping and knocking the endoscope to a hard surface or object (handling issue).The investigation is ongoing and the conclusive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is submitted to provide additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2.G2 - checked "other" to correct the country to spain.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the cause of the event likely occurred due to stress and/or handling issues.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.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.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 22-nov-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: 13056301
• MDR Text Key: 286361406
• Report Number: 8010047-2021-16536
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170287879
• UDI-Public: 04953170287879
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,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: 11/24/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/28/2021; 02/16/2022; 11/08/2022
• Supplement Dates FDA Received: 12/30/2021; 03/07/2022; 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2013
• 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