MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-3 100V; ENDOSCOPE REPROCESSOR

Model Number OER-3

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report 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 medical systems corp.(omsc) was informed from the user facility that even though the detergent replacement indicator which indicated the detergent tank became empty blinked, the user reprocessed the unspecified endoscope with the subject device.After the reprocessing, the user used the endoscope to the patient.The field service checked the subject device at the facility and found that there was air in the tube which was connected the detergent tank and the reprocessing basin, consequently the detergent supplying had trouble.There was no report regarding patient injury related to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc could not investigate the subject device.Based on the reported information, omsc concluded the reported phenomenon was attributed to the inappropriate reprocessing by the user, such as the user used the subject device even though the detergent replacement indicator which indicated the detergent tank became empty blinked.If additional information becomes available, this report will be supplemented.

• Brand Name: OER-3 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: 10205152
• MDR Text Key: 213252556
• Report Number: 8010047-2020-03715
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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: No Information
• Device Model Number: OER-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1