MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MAINTENANCE UNIT

Model Number MU-1

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information available for this event as yet.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.The user¿s complaint was confirmed.Upon inspection and testing, found ac inlet broken.Found missing plastic cover on main switch.Also found air pressure fluctuated due to worn out air joint unit and connector socket and corrosion inside bottom chassis.Four suction feet were worn out with weak power suction.The rest of other functions tested ok.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.As seven years have elapsed since the manufacture of the product, it is likely that the issue was caused by accidental failure due to aging degradation.

Event Description

As reported for this event, during reprocessing the device had a bad connector and broken power plug.There is no patient involvement and no harm reported to any patient.

• Brand Name: MAINTENANCE UNIT
• Type of Device: MAINTENANCE UNIT
• 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: 10760094
• MDR Text Key: 224665915
• Report Number: 8010047-2020-08314
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MU-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2013
• 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