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

Model Number MU-1

Device Problem Mechanical Problem (1384)

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

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the reported issue was confirmed.Furthermore, the evaluation uncovered the following: broken protective cover and it's plastic cap torn off/found ac inlet at rear with crack and unit showed no air pressure on air gauge due to damaged air joint unit with its front piece broken off/found tubing¿s of old type and bent and air pressure was low due to faulty air pump unit.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, the maintenance unit was not holding a suction.A leak tester hose was replaced but was still loose and not sealed/ not working properly.Upon inspection and testing of the returned unit, found 4 suction feet at the bottom with weak suction force and power switch was damaged.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section g2 was corrected to accurately identify the report source as a healthcare professional.Based on the results of the investigation, the definitive root cause of the cracked alternating current inlet and the damaged power switch could not be determined.It is possible that the issues were caused by the application of excessive force.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

The device history review (dhr) of the device was initiated in order to confirm that there were no manufacturing anomalies, special employment, or variations.However, since the product was manufactured more than 15 years ago and the dhr retention period had expired, a review of the manufacturing records was not possible.

• 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: 16315941
• MDR Text Key: 309281764
• Report Number: 3002808148-2023-01171
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• 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: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• 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