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

Model Number OER-5

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

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

Event Date 07/30/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing, it was found the following.- during the reprocessing with the subject device, the error e16 which indicated that it takes too long to fill the reprocessing basin with disinfectant solution occurred.The user checked the subject device and found the foreign material (pieces of rubber) in the reprocessing basin.There was the possibility that the filter of the circulation port might be clogged by the foreign material and the error e16 might occur.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device was not returned to omsc but the foreign material was returned to omsc.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to omsc for evaluation, but the foreign material was returned to omsc.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc checked the subject foreign material was and found that the returned foreign material was a black, elastic substance.As a result of performing an organic qualitative analysis on the foreign material for the substance investigation, it was found that the waveform of the foreign material was equivalent to that of the pipeline hose of the subject device.From this result, color and characteristics, omsc considered that the foreign material was a substance similar to the pipeline hose of the subject device.Omsc surmised that there was the possibility that a part of the wetted surface of one of the pipeline hoses deteriorated and peeled off and it was washed away as the foreign material.Subsequently there was the possibility that when the disinfectant was collected, the foreign material was moved to the disinfectant tank.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: 12375590
• MDR Text Key: 280579800
• Report Number: 8010047-2021-10804
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1