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

Model Number OER-3

Device Problem Degraded (1153)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, after a scope was reprocessed in the device, black foreign material was found to be stuck in the water supply nozzle.The black foreign material was pulled out of the nozzle.The device was pulled out of service due to the presence of the foreign material.The scope was reprocessed again in another automatic endoscopy reprocessor prior to being used.There is no patient involvement and no harm to any patient.

Manufacturer Narrative

This device is not sold in the us but a similar device is.An evaluation for the device is completed.The user¿s complaint was confirmed.The flow hose connecting the flow pump and the three-way valve of the device was removed.An incision made in the hose lead to the finding of deterioration with peeled off rubber pieces.The outlet hose that connects the three-way valve and the water supply nozzle was also removed and inspected with an incision.The damaged hoses were replaced.Test runs were made for the device cycles to confirm that no rubber pieces were coming out.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

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 (dhr) found no deviations that could have caused or contributed to the rubber fragments that were found in the hose.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because the hose had deteriorated (fragmented rubber pieces) from the repeated/long-term exposure to the chemicals in the disinfectant solution.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15077283
• MDR Text Key: 304807684
• Report Number: 9610595-2022-00175
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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