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

Model Number OER-4

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) informed the disinfectant solution for the device expired too soon.It happened only a couple of days after replacing the solution or about ten reprocessing cycles.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus re-evaluated the event reported in the initial report and determined that the failure mode is not a mdr reportable malfunction.Therefore, this report is being submitted to retract the mdr on the event.

• 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
• MDR Report Key: 11206264
• MDR Text Key: 227929446
• Report Number: 8010047-2021-01664
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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: Other
• Device Model Number: OER-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1