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

Model Number MU-1

Device Problems Break (1069); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device returned to the service center for evaluation.The customer¿s complaint of ¿ can¿t be powered on and off¿ was confirmed.The front power switch was found hard to turn on due to a torn plastic cap and the power switch was damaged with a crack.In addition, the ac inlet at the rear was found damaged with a crack.Also found air joint unit and connector socket worn out.Found 4 suction feet at the bottom with weak suction force.The top cover and main chassis were rusted inside.All aspect of the unit functioned normal.

Event Description

The service center was informed that the power switch would not power on and off.There was no patient involvement reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the broken ac inlet would likely be caused by aging degradation or damage due to excessive force, dropping, or hitting a hard object.The legal manufacturer determined the other issues identified in the initial report are not reportable malfunctions (i.E., damaged power switch, worn out air joint unit and connector socket, the four suction feet with weak suction force, and rusted top cover and main chassis).Per the legal manufacturer, there is no potential for these issues to cause or contribute to death or serious injury if the malfunctions were to recur.

• 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
• MDR Report Key: 10950330
• MDR Text Key: 226705073
• Report Number: 8010047-2020-09862
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 04953170060434
• UDI-Public: 04953170060434
• Combination Product (y/n): N
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MU-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1