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

Model Number MU-1

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus (b)(4) pty ltd was informed that power cord receptacle of the device was broken.It was also found that the power switch and output socket were defective and had to be replaced.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device inspection by olympus australia pty ltd confirmed followings: the suction power of the foot was reduced.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus medical systems corp.(omsc) assumed that the defect of power cord receptacle was caused by followings: accidental failure due to aging.Physical stress such as falling due to user handling.If significant additional information is received, this report will be supplemented.

• 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: 11320009
• MDR Text Key: 231700007
• Report Number: 8010047-2021-02542
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MU-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1