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

Model Number MU-1

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The maintenance unit was returned to olympus for evaluation and service.The evaluation found the air pressure to be low and fluctuated due to a faulty air pump unit, worn out air joint unit/connector socket and older type of tubing.In addition, the power switch at front was damaged with cracked protective cover and its plastic cap was torn off.The ac inlet at the rear end was found damaged with crack.The four suction feet at the bottom was found to have a weak suction force.The device was serviced and inspected to olympus functional standards and an electrical safety check was performed and then returned to the user facility.As part of our investigation into this report, the instrument history was reviewed and found that the device was purchased by the facility on december 5, 2005 and this is the first time that the device was returned to olympus for service; therefore, wear/tear cannot be ruled out as a contributory factor to the reported device issue.

Event Description

The customer returned the unit for service.During the evaluation of the device, it was noted that the power cord receptacle failed.There was no report of patient or user harm associated with this report.

• 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: 11032287
• MDR Text Key: 225928799
• Report Number: 8010047-2020-10606
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 04953170060434
• UDI-Public: 04953170060434
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 06/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• 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