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

Model Number OER-PRO

Device Problems Crack (1135); Degraded (1153)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to service the device.The fse identified the black particles and also a broken lid.The fse drained the acecide, flushed the tank, and replaced the required tubes and the lid.The device passed final tests and inspections and was ready to be used upon completion.This event is under investigation.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported the customer noticed black particle recurrence in an endoscope reprocessor during reprocessing.It was further reported the device had been used over 10 times and reprocessing was completed with another device.As reported, no patient death, injury, or infection occurred due to this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 8 years since the subject device was manufactured.Based on the results of the investigation, the probable causes for a cracked lid include: an external impact to the lid with a scope when it was closed.Regarding the black foreign object in the washing basin, it is likely the hose in the subject device may have peeled off due to age deterioration.Design of the device or manufacturing cannot be confirmed as factors to cause the event.The most probable cause for the reported event is user handling.The instructions for use have the following statement which can detect the event: "before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.- the lid is not cracked, broken, or otherwise damaged.".

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section g2 was corrected with information that was inadvertently omitted from the supplemental report.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11577375
• MDR Text Key: 243352651
• Report Number: 8010047-2021-04215
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2024

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-PRO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 05/13/2021; 02/07/2023; 05/03/2024
• Supplement Dates FDA Received: 05/20/2021; 03/02/2023; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2012
• 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