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

Model Number MU-1

Device Problems Break (1069); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

B3: customer later reported that the event occurred on (b)(6) 2023.However, the aware date of (b)(6) 2023 was confirmed.Customer did not provide an explanation for the discrepancy upon request.As such, b3 is not known.The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation the customer's originally reported issue of damaged ac power inlet was confirmed; the device would not accept a power plug properly.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that, during the leak testing of their maintenance unit endoscope device during routine maintenance prior to cleaning and reprocessing, it was discovered by the endoscope cleaner that the alternating current (ac) power inlet was damaged, which prevented the ac plug from fitting into the device properly.There were no reports of patient or user harm associated with this event.

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 of the suggested event could not be concluded, although it can be presumed that the defect was caused due to breakage of the inlet.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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17746567
• MDR Text Key: 323700113
• Report Number: 3002808148-2023-09850
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170060434
• UDI-Public: 04953170060434
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• 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