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

Model Number OER-PRO

Device Problem Obstruction of Flow (2423)

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

Event Date 09/01/2021

Event Type  malfunction  

Event Description

As reported for this event by the customer, during reprocessing the device cycle time is extended to 33 to 34 minutes.There were no water pressure issues at the facility and the filters being used are olympus brand.After the external water filters and the internal water filters were replaced, the cycle time reduced and was 30 minutes and not less than that.There is no patient involvement.

Manufacturer Narrative

Field service engineer (fse) went on site to evaluate and fix the device.After the 0.45 micron water filter was replaced and air purged from the internal water filter the cycle time decreased to 26 minutes.Fse verified that device was functional per the original equipment manufacturer instructions.The covers of the oer-pro were not removed so an electrical safety check was not required.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Due diligence was executed for this event with no additional information available.The device history record review confirmed that device conformed to specifications at the time of shipping.There is no available repair history for this device.The root cause of the event of extended cycle time cannot be conclusively determined.It is likely that water supply quantity dropped because the user did not purge air after replacing water filter, and/or the filter was clogged.The event may also have occurred because the user was using the water filter that exceeded recommended period by olympus, and/or components in tap water was concentrated/increased.The instructions for use includes the following statements which can prevent the issue: chapter 7.2.Replacing the water filter (maj-824): replace the water filter at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever an error code indicating water supply insufficiency [e01] is displayed.The water filter should be replaced by following the flow shown below.If air gets in the water filter housing, it may extend the process time.In case of an irregularity such as extension of the process time or lack of water supply, drain the air as described in draining air in the water filter housing on page 165.

• 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: 12528121
• MDR Text Key: 280875470
• Report Number: 8010047-2021-12236
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1