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

Model Number MU-1

Device Problems Break (1069); Loose or Intermittent Connection (1371); Pressure Problem (3012)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

The customer reported to olympus whenever you turn the machine on, whenever you pull the plug out to release the air it does not release the air.Device was working fine in morning but about mid-morning it stopped.There was no death or injury reported due to the event.

Manufacturer Narrative

The evaluation confirmed the reported issue, found air gauge/leak tester got loose at times due to worn out air joint unit and connector socket.In addition, found air flow rate low due to faulty air pump unit.Also found tubing of old type.Found power switch at front was damaged with cracked protective cover and its plastic cap torn off.Found 4 suction feet at the bottom with weak suction force.Need to replace listed parts.The rest of other functions tested ok.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A correction is being made to b5 and h6 to accurately reflect the reportable malfunction.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the broken power switch cannot be determined at this time.Olympus will continue to monitor field performance for this device.

Event Description

Upon inspection of the customer returned device, the power switch was found broken.This medwatch report is being submitted for the malfunction found at evaluation.

• 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: 14253165
• MDR Text Key: 291311766
• Report Number: 8010047-2022-07365
• Device Sequence Number: 1
• Product Code: KNT
• 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
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2008
• 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