MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that the subject device was out of detergent and the detergent replacement indicator blinked, but the user reprocessed the two cyf-va2s without refilling it with detergent.The two cyf-va2s were not used in the procedure and were reprocessed after replenishing the subject device with detergent.The user did not know the function of the detergent replacement indicator.The event date was unknown.Other detailed information was not provided.There was no report of patient injury associated with the event.

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.The root cause of this event was that the cleaning and disinfection process was carried out by a user without understanding the meaning of the blinking detergent replenishment indicator lamp on the front panel, so the event occurred due to a mistake in the user's method of managing the residual amount of detergent.The event can be detected/prevented by checking and replenishing the amount of detergent in the detergent tank according to "3.4 checking and replenishing the remaining amount of detergent" in "chapter 3 inspection before use" of the oer-4 instruction manual.Olympus will continue to monitor field performance for this device.

• Brand Name: OER-4 100V
• Type of Device: ENDOSCOPE REPROCESSOR
• 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: 13050915
• MDR Text Key: 286249383
• Report Number: 8010047-2021-16496
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2012
• 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