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 03/09/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, that the power switch on the maintenance unit was cracked or scratched but the metal parts of the power circuit (switch electrodes/harness and so on) was not exposed, however, the switch cover was cracked.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation.The customer's complaint was confirmed, the evaluation found the power switch at the front was damaged, protective cover cracked and the plastic cap was torn.In addition to what's reported in b5, the following nonreportable malfunctions were identified: one of the rubber foot came off at the bottom and another three had weak suction force; top cover had deep paint scratches; air pressure fluctuated when wiggling the air gauge, due to air joint unit and front connector socket was worn out.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 reported issue was confirmed, the protective cover of the power switch is cracked.However, the specific cause of the cracked protective cover could not be established at this time.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: 16782207
• MDR Text Key: 313727551
• Report Number: 3002808148-2023-03986
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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: 03/24/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• 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