MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-AW

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

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

Event Date 09/23/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that it was found black particles in the disinfectant solution of the subject device during the reprocessing.The intended procedure was not delayed more than 15 minutes.There was no patient injury associated with this report.

Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4) for evaluation.Olympus (b)(4) checked the subject device.It was found some black particles inside the disinfectant tank and disinfectant tank hose 1, of the subject device.Its tank hose must have been replaced with new one as repair.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based on the report of olympus china and it report said there was a need to replacement of tank hose 1 and the former similar case, omsc presumed there was the possibility this phenomenon was attributed to the following; the inner surface of the hose might have peeled off due to deterioration.When the disinfectant solution was pumped up, it might have appeared as the foreign substances and was reprocessed with those foreign substances.Therefore, it might have been mixed with the disinfectant solution.If additional information becomes available, this report will be supplemented.

• Brand Name: ENDOSCOPE REPROCESSOR
• 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: 12669557
• MDR Text Key: 281426989
• Report Number: 8010047-2021-13449
• 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: foreign,user facility
• Type of Report: Initial
• Report Date: 10/21/2021

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: No Information
• Device Model Number: OER-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1