MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. MAINTENANCE UNIT

Model Number MU-1

Device Problem Power Problem (3010)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the maintenance unit back power receptacle wouldn¿t work.The event was found during reprocessing.There was no report of patient harm associated with this event.The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The alternating current (ac) inlet at the rear was damaged and pushed inward, resulting in the inability to connect power cord.This report is being submitted for the malfunction found at estimation (damaged ac inlet).

Manufacturer Narrative

During inspection and testing, the customer's allegation was confirmed.In addition, air pressure fluctuated due to worn out air joint unit and connector socket.The rear panel had a deformity.There were 4 suction feet at the bottom with a weak suction force.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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 root cause could not be determined.It was confirmed that the power inlet was damaged but the cause of the damage could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: MAINTENANCE UNIT
• Type of Device: MAINTENANCE UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15738165
• MDR Text Key: 307077603
• Report Number: 3002808148-2022-03847
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170060427
• UDI-Public: 04953170060427
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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