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

Model Number MU-1

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The reported issue was confirmed as the on/off power supply switch was found broken.Additionally, peeling paint located on the chassis and the cover unit's external surface was identified.Once the external top cover was disassembled to inspect internally, components such as valves, plastic tubing as well as the scope socket were worn.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The regional repair center (b)(4) was informed that a customer maintenance/leak test unit was returned for a reported "switch broken".During inspection and testing, the on/off power supply switch was found broken (reportable).No patient injury or harm was reported to olympus.

Manufacturer Narrative

This supplemental report was submitted to provide a correction.The become aware date (g3) on the initial mdr report.The correct aware date is (b)(6) 2021.The investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is being submitted, to provide the results of the legal manufacturer¿s investigation.And the results of the device history records (dhr) review.Initial report correction to g3: (b)(6) 2021.The dhr for this device were reviewed.And all records indicated, the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined, the probable cause of the failure is likely, due to normal wear.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• 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: 13082216
• MDR Text Key: 286731238
• Report Number: 8010047-2021-16778
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 04953170060434
• UDI-Public: 04953170060434
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: 11/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2009
• 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