MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEO ADAPTER

Model Number A10-T2

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus inspected the device at the service department and found that the foreign matter adhering to the main body and around cover glass of the device.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc for evaluation but was returned to an olympus service operation repair center (sorc) in japan.The evaluation of the device by the sorc confirmed following: an internal part was wet.An o-ring was come off and other internal parts damaged.It seems that water containing the foreign material was invading the inside of the device due to deforming the internal parts when unexpected stress was applied, and the material remained at the main body and around cover glass of the device.

• Brand Name: VIDEO ADAPTER
• Type of Device: VIDEO ADAPTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10872889
• MDR Text Key: 218512302
• Report Number: 8010047-2020-09179
• Device Sequence Number: 1
• Product Code: CGI
• Combination Product (y/n): N
• PMA/PMN Number: K955404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A10-T2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1