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

Model Number OER-ELITE

Device Problems Device Reprocessing Problem (1091); Decrease in Pressure (1490)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

The customer spoke with an olympus endoscopy support specialist (ess) and it was determined that the water filter was placed upside down.After the customer corrected the water filter placement, the water pressure and washing time were the expected pressure and length of time.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The investigation determined that it was likely that the decreased water pressure and increased washing time was caused by the user placing the water filter upside down.The instructions for use (ifu) addresses this failure: user can prevent the suggested event by replacing water filter appropriately in accordance with the following ifu.Chapter 8 replacement of consumable items: 8.4 replacing the water filter (maj-824 or maj-2318).User facility is currently being performed.A supplemental report will be submitted if additional information becomes available.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, that since changing the water filter, the user facility has been experiencing an extended wash time of up to 40 minutes when using the endoscope reprocessor.This has not been isolated to a one scope.The gauge of the water system showed no pressure.The water supply was at a very low pressure.There were no reports of patient harm associated with this event.Related patient identifiers: (b)(6) (maj-824 ¿ water filter) and (b)(6) (oer-elite).

• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17015482
• MDR Text Key: 317165057
• Report Number: 9610595-2023-08150
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201920
• 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
• Report Date: 05/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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