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

Model Number OER-4

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc performed analysis of component of the white crystalline material, oxygen, carbon and silicon were detected mainly.Therefore the it was considered that the white crystalline material was mixture of the peracetic acid (disinfectant solution) and some kind of silicone-based material which might be antifoam agent or other medical agent.It was considered that there was the possibility that these might be mixed into the reprocessing basin, or these could not be rinsed completely then remained in the reprocessing basin.However the exact cause of the reported event could not be conclusively determined.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that despite the user used the subject device as per normal, the white crystalline material had become to adhere thickly to the reprocessing basin of the subject device along the retaining rack.The user found the above issue during the reprocessing.The subject device had functioned without any problem.There was no report of patient injury associated with 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11587597
• MDR Text Key: 242894489
• Report Number: 8010047-2021-04340
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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