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

Model Number OER-PRO

Device Problems Obstruction of Flow (2423); Device Handling Problem (3265)

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.Upon evaluation of the device, field service engineer (fse) observed consistent e95 error messages that were caused by a clogged sensor and pump.There was debris clogging the sensor; the debris was congealed endoquick detergent.This was preventing the fluent spinning of the sensor wheel.Fse replaced the sensor and other necessary parts.The pump was then primed.Fse ran test cycles and there were no further issues, including the e95 error message, once the repair was done.Equipment was repaired and verified to original equipment manufacturer specifications.Software attributes were verified and confirmed.Equipment passed the electrical safety test.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Field service engineer (fse) went on site to evaluate the customer reported issue of not being able to run a cycle due to flashing lights.Fse found that the device also gave a detergent alarm as well as the disinfectant (lcg) warning light.Customer further reported to fse that the device was not in use for several weeks and had not been prepared for long-term storage, as is required per the instructions for use.The lack of preparation of the device for long-term storage, leads to the congealing of detergent in the tubing, thereby causing the issues of the device.There is no patient involvement.

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 2 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the user did not read the instructions for use (ifu) thoroughly and did not have enough knowledge on equipment.This is the root cause of the suggested event.Ifu says about the suggested event as below: (user can prevent the event.) ¿7.16preparing the reprocessor for long-term storage when the equipment will be stored for more than 14 days, follow the procedure described in this section¿ olympus will continue to monitor the field performance of this device.

• 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: 13345306
• MDR Text Key: 295492663
• Report Number: 8010047-2022-01950
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

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 Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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