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

Model Number OER-ELITE

Device Problem No Device Output (1435)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device inspection, that the endoscope reprocessor exhibited the connecting connector was damaged.There were no reports of 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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the likely cause of the reported event, is due to the user may have applied stress toward wrong direction.Which caused, the external stress being applied to lock lever of the connecting tube, which led, to breakage of the tube.Subsequently, the tube was unable to be connected.The event can be detected/prevented, by following the instructions for use (ifu), sections which state: chapter 5: inspection and preparation before use: 5.7: inspecting the connecting tubes and leak test air tube before using the reprocessor.Always check, that there is no irregularity regarding the following points on the connecting tubes and leak test air tube.All tubes should be free of cracks, breaks, fissures, scratches or stains.There should be no cracks in the lock levers of connecting tube connectors and leak test air tube connectors.There should be no bends or breaks in the pin of connecting tubes connector and leak test air tube connector.The tube should not be easy to disconnect once connected.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19082218
• MDR Text Key: 339913208
• Report Number: 9610595-2024-07560
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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: Other
• Device Model Number: OER-ELITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2022
• 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