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

Model Number OER-4

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/30/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that the water filter (which filters bacteria and microscopic debris in tap water) of the subject device has not been replaced for a year (the user may have used the poor reprocessing endoscopes or accessories for the patient).The user also reported that there seemed to be no algae breeding inside the water filter case but it will be checked if there is any dust on the mesh filter at the subject device side attachment port of the water supply hose.There was no patient injury associated with this report.

Manufacturer Narrative

In the several days after, the water filter of the subject device was replaced by the field service engineer of olympus and it was found that the water filter had been clogged.Also it was found there was sufficient cleaning because the user checked the disinfectant solution to be effective with the test strip every time.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based on the report of user and the field service engineer of olympus, omsc confirmed the user facility had not replaced the water filter of the subject device for over a year and found the water filter was clogged by the user handling.The water filter need to be replaced at least once a month.If additional information is received, this report will be supplemented.

• 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: 12879938
• MDR Text Key: 283168172
• Report Number: 8010047-2021-15141
• 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
• Report Date: 11/28/2021

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: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2021
• Initial Date FDA Received: 11/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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