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

Model Number MU-1

Device Problems Crack (1135); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Customer called the olympus technical assistance center (tac) support to troubleshoot the device.Customer reported the unit was accidentally dropped in the sink and blew the fuse.Customer was transferred to repairs to have the unit sent in for evaluation as it is not safe to just try and use.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The evaluation uncovered the unit with water contamination inside the main chassis, top cover, rear panel, and other screws.Additionally, the ac inlet in the rear was damaged and pushed inside, the power switch in the front was damaged with cracked protective cover and plastic cap was torn off, the tubing was bent inside and of old version type.The air joint unit and the connector socket in the front was worn out.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported to olympus during preparation for use, the maintenance unit fell into the sink and tripped the breaker.Upon inspection and testing of the customer returned device, water was found inside the main chassis, the ac inlet rear was damaged/ pushed inside and the power switch in the front was damaged with a cracked cover.This report is being submitted as a mdr based on this evaluation result.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation, device history record review, and additional information provided by the customer.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The exact root cause could not be determined.The investigation determined damage to the inlet and damage to the power switch.The fuse was melted, and there is wear on the endoscope socket and tears on the switch cap.Olympus will continue to monitor the field performance of 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14635321
• MDR Text Key: 301488942
• Report Number: 8010047-2022-09667
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170060434
• UDI-Public: 04953170060434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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