MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical assistance center (tac), the customer reported that the flow of the reprocessing cycle has weakened.Customer replaced the filter, but this did not resolve the issue, and asked that an olympus field service engineer (fse) be dispatched to evaluate the device; fse visited the user facility, changed all 3 filters (1 in the processor and 2 on the wall), and suggested that user change the 1 filter monthly, as this should prevent the need to replace the other 2 filters as often.The device is not expected to be returned.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that while using the endoscope reprocessor, the flow of the reprocessing cycle has weakened; the cycle used to take about 27 minutes and currently takes about 32 minutes.The issue has been occurring during reprocessing and there was no patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the water flow became weak due to the filter being clogged by dirt.The following information is stated in the instructions for use (ifu): ¿chapter 7 routine maintenance 7.2 replacing the water filter (maj-824) replace the water filter at least once a month to prevent contamination of the rinse water.Note ·filter life varies depending on a number of factors including incoming water quality and use volume.·using at least a prefilter (0.45 micron or less) can extend the life of the water filter.If the prefilter is properly installed, the water filter and the prefilter should be replaced at least once every 6 months.For information on the water pre-filtration system, contact olympus.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15783386
• MDR Text Key: 307310489
• Report Number: 9610595-2022-03849
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• 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: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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