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

Model Number OER-ELITE

Device Problem Break (1069)

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

Event Date 04/12/2024

Event Type  malfunction  

Manufacturer Narrative

The field service engineer replaced a1 connector and verified it in according to original equipment manufacturers (oem) instructions at the customer facility.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the endoscope reprocessed a1 port was broken.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field: h6 (component code is being corrected to 4733 - connector/coupler additional information added to field d9, h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 years since the subject device was manufactured.An olympus field service engineer (fse) was dispatched to the user facility and the customer's allegation of a1 port broken was confirmed.Based on the results of the investigation, it is likely that the user hit the connector something hard or stress to the connector toward loosening direction was accumulated, leading to breakage of the connector.However, root cause of the suggested event could not be identified.The event can be detected/prevented by following the instructions for use which state: chapter 5 inspection and preparation before use.5.6 inspecting the connectors.Check the following for each connector.¦ the connector should be fixed firmly.¦ the o-rings should be free of irregularities such as cracks, tears, or dents.If any irregularity is found, do not use the reprocessor and contact olympus.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 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: 19210060
• MDR Text Key: 341818124
• Report Number: 9610595-2024-08874
• Device Sequence Number: 1
• Product Code: FEB
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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-ELITE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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