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

Model Number OER-PRO

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that the error occurred during reprocessing.The device was inspected on site by a field service engineer (fse) and there was no damage or abnormalities observed.The customer notified that they have not been disinfecting the water supply piping.During the evaluation there was no fluid found inside the device.The dirt was cleaned off of the internal fluid sensor and the device completed a reprocessing cycle successfully.There was no injury reported associated with this failure to disinfect the device.No additional information was provided.

Event Description

A biomedical equipment technician from a user facility reported that during reprocessing an error code e51 internal fluid leak error occurred on the endoscope reprocessor.There was no injury due to the reported issue.No additional information was provided.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿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 root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the event occurred by the user handling such as inadequate replacement of water filter.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10226330
• MDR Text Key: 224633058
• Report Number: 8010047-2020-03851
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2012
• 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