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

Model Number MU-1

Device Problems Corroded (1131); Crack (1135)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

As reported, the device power switch has the membrane cover ripped off and therefore not protected and the receptacle where the power cord plugs in is cracked and should be replaced.There are some oxidation and some moisture got in the unit.The issue found at reprocessing.There is no patient involvement associated on this reported event.No user injury reported.

Manufacturer Narrative

The subject device was received with no accessories.Device inspection and evaluation found the customer reported issue was confirmed.Inspection found the power switch¿s led at front not lighted, damaged with cracked protective cover.The ac (alternating current) inlet at rear was damaged with crack.In addition, found top cover rusted inside.In addition, 4 suction feet at the bottom with weak suction force.Found air pressure low due to faulty air pump unit.The identified needs to be replaced and requires parts general interior cleaning.The rest of other functions tested normal.Investigation is ongoing.This report will be supplemented accordingly following completion of investigation.

Manufacturer Narrative

This report is being supplemented, to provide additional information, based on the legal manufacturer's final investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, the cause of the damaged power switch and ac inlet cannot be identified.Olympus will continue to monitor field performance for this device.

• 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: 13502051
• MDR Text Key: 285418418
• Report Number: 8010047-2022-02699
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2013
• 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