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

Model Number MU-1

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus service center for evaluation and the reported issue was confirmed.The connector socket in the front was deformed, causing the leakage tester to become loose.In addition, the power switch with a cracked protective cover and the plastic cap torn was off.The alternating current (ac) inlet in the rear was damaged with a crack.The air pressure was low due to a faulty air pump unit.The tubing was an old type and bent.Four suction feet at the bottom of the housing had weak suction force.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus that the socket was loose on the maintenance unit.The issue was found at reprocessing.No patient involvement was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information provided by the facility and the legal manufacturer¿s investigation.Please see updated sections: e2, e3, g2, g3, g6, h2, h6, and h10.Per the customer, the cord that connected to the machine was loose.The cord had been loose for a while.When the machine was turned on and connected to the scope to test for leaking, the cord was shaking loose and did not making a seal.There was a risk of the leak tester not being done correctly as the cord was not staying connected.When the machine vibrated, the cord became detached from the connection.The technicians were aware when the cord was loose and would retighten it.This issue had been ongoing for the last couple months.There was no damage to the device.The device had not been dropped.The device always sat on the shelf.There was no damage to the cord.The cord just had wear and tear.The facility was still able to use the device.The facility had three additional devices that were the same model and was also able to get a loaner.There was no injury to the patient and no alarms were received.The legal manufacturer performed an investigation.The dhr review could not be performed as the device was manufactured more than fifteen years ago and the record could not be confirmed.The device was manufactured in 1999, delivery date: (b)(6) 2000.The root cause of the reported issue could not be conclusively specified.The probable cause was caused by the user such as accidental failure due to aging deterioration or dropping or hitting a hard object.

• 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
• MDR Report Key: 11389324
• MDR Text Key: 234040345
• Report Number: 8010047-2021-03070
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 04953170060434
• UDI-Public: 04953170060434
• Combination Product (y/n): N
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 02/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1