MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

Model Number CV-180

Device Problem Key or Button Unresponsive/not Working (4063)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

A user facility reported to olympus that a front panel button did not function.The problem, as reported to olympus, was identified during preparation for use.There was no patient injury, associated with the problem, reported to olympus.

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem of "front panel button did not function" could not be confirmed.The evaluation findings are as follows: buzzer did not function due to printed circuit board failure.Dust inside unit.Cable was difficult to insert in a front panel connector (pip).Rust on rear panel.Scratch on front panel and top cover.Corrosion on the chasis.The investigation is ongoing and the 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 being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿do not apply excessive force to this video system center and/or other instruments connected.Otherwise, damage and/or malfunction can occur.Do not wipe the external surface with hard or abrasive wiping material, the surface will be scratched.Use this instrument only under the conditions described in ¿transportation, storage, and operation environment¿ and ¿specifications¿ in the appendix.Otherwise, improper performance, compromised safety and/or equipment damage may result.¿ based on the results of the investigation, a definitive root cause could not be determined.During the device evaluation, the user¿s report could not be duplicated.Olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• 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: 14290463
• MDR Text Key: 299601587
• Report Number: 8010047-2022-07645
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

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: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2012
• 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