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

Model Number MU-1

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The repair center found the power switch on the front of the device was damaged with a crack, its led did not light, and the plastic cap was torn off.Additionally, the power cord receptacle on the back of the device was damaged with a crack.The device was repaired and returned to the customer.Based on the investigation results, the device is approximately 14 years old and it is presumed that the event was caused by accidental failure due to aging degradation or by inappropriate user handling.As the results of the device history record review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

A user facility reported a broken switch on a maintenance unit.No patient harm or injury was reported.No additional information has been obtained.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 8010047-2020-10123.As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The oem determined that the reported broken power switch and cracked power inlet were caused by aging degradation or user handling.Olympus will continue to monitor complaints for this device.

• 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: 10978995
• MDR Text Key: 220540464
• Report Number: 8010047-2020-10123
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 09/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1