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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the endoscope reprocessor had broken yellow connectors in the basin connecting tubes and that they were not staying attached.Connecting tube cannot be connected to the channel connector in the reprocessing basin.The issue was found during reprocessing.The issue has been resolved by the field service engineer.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information, and the legal manufacturer's investigation.D8 has been corrected, and h4 has been updated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over eight years since the subject device was manufactured.Based on the results of the investigation, it is likely the connecting tube could not be connected because the connector was broken by being hit with a hard object or loosened.Due to the looseness of the connector, it is likely that the user applied stress to the in the loosening direction, and the stress accumulated leading to the reported event.However, the root cause of the events could not be determined.The suggested event is detectable and preventable by handling equipment in accordance with the following ifu.Chapter 3.Inspection before use: 3.3 inspecting the connectors.Check the following for each connector.-the connector should be fixed firmly.-the o-rings should be free of abnormalities such as cracks, tears, or dents.Do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.Olympus will continue to monitor the field performance of 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: 18475538
• MDR Text Key: 332441890
• Report Number: 9610595-2024-00504
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• 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