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

Model Number AR-T10E

Device Problems Component Missing (2306); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for physical evaluation.Preliminary findings are reported.The definitive cause of the customer's experience can not be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals the following: the coupler unit is bent causing an off-centered image.The er ring is detached and missing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported that a video adapter was thought to have sustained being dropped.No obvious physical damage was identified by the customer.There was no patient contact/impact related to this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the evaluation of the device and the legal manufacturer¿s final investigation.These component failures found during evaluation were attributed to mechanical shock, as the customer reported that they had dropped the video adapter.

• 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: 10953182
• MDR Text Key: 226694477
• Report Number: 8010047-2020-09882
• Device Sequence Number: 1
• Product Code: GCJ
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: AR-T10E
• Device Lot Number: AC20162438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1