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

Model Number OER-3

Device Problem Device Reprocessing Problem (1091)

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

Event Date 06/30/2020

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 that before the reprocessing the user checked the concentration of the disinfectant solution, it was no problem.Furthermore during the reprocessing the user checked the concentration of the disinfectant solution, it was insufficient.The samples were taken from the disinfectant removal port of the subject device.The user exchanged the disinfectant to new one and the reprocessing was completed.The user surmised that the water drop in the reprocessing basin might have been mixed into the sample, and it might have affected to the result of the concentration of the disinfectant check.There was no report regarding patient injury and damage of the endoscopes related to the event.

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc could not investigate the subject device.Omsc could not review the manufacture history (dhr) of the subject device because the serial number of the subject device was unknown.However omsc considered that the subject device had no irregularity, because omsc only shipped devices which passed the inspection.The exact cause of the reported event could not be conclusively determined.However, based on the information from the event report, there was the possibility that this phenomenon was attributed to the effect by the adhering a waterdrop and so on onto the lid, basin, etc.Regarding the concentration check of the disinfectant solution during the reprocessing.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: 10314288
• MDR Text Key: 200060092
• Report Number: 8010047-2020-04754
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1