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

Model Number OER-PRO

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

Olympus technical support engineer was informed by the nurse at the user facility via telephone that the disinfectant drawer from the endoscope reprocessing machine is stuck open and will not close.The nurse was trying to lift the rear of the drawer, but it would not move.No death, injury or infection was reported to olympus.

Manufacturer Narrative

During troubleshoot, there were no partially pierced bottles.There was no damage to the bottle cutters and or drawer runners.The call was placed on hold; the nurse walked away for a minute and when the nurse returned someone in the room ¿touched something and now the drawer was closed and they could not open it¿.It was unknown how the staff was able to close the drawer.The nurse was also unable to perform a liquid chemical germicide (lcg) load and was advised to perform an lcd drain.The drain was completed but could not perform the lcg load as there was no acecide available and at another location in the hospital.The customer would call back when the acecide became available.The nurse replied via email a few days later and further reported that the problem has been resolved as the customer was able to close the disinfectant drawer and later able to perform an lcg load normally.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Manufacturer Narrative

Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.Correction to date rec¿d by mfr of the initial medwatch.The aware date should be (b)(6) 2022.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 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the user applied excessive force to the disinfectant bottle drawer, or inserted it halfway but pulled out.Then the drawer was locked, causing the suggested event.A definitive root cause cannot be identified.The instructions for use (ifu) warns the user not to use the equipment if any irregularity is observed as below: ¿ the oer-pro requires routine maintenance and inspection.In addition to checks before use, the person in charge of maintenance and administration of the medical equipment at the hospital should periodically check all of the items described in this manual.If any irregularity is observed, do not use the equipment and inspect it as described in 8.1, ¿troubleshooting guide¿ on page 274.If the irregularity is still present, the equipment must be repaired prior to next use.¿ 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: 13664202
• MDR Text Key: 296765483
• Report Number: 8010047-2022-03923
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• 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