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

Model Number OER-ELITE

Device Problem Connection Problem (2900)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

The referenced aer is not expected to be returned.However, the investigation is in progress.If any additional information becomes available, this report will be supplemented accordingly.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Event Description

During a compliance investigation, olympus became aware that on or about (b)(6) 2021, an olympus field service engineer (fse) identified an error in an off-label way that the customer automatic endoscope reprocessing (aer) machine was configured.It was reported the aer was using connectors from a jig while reprocessing endoscopes.The jig (rv111100) is noted to be a separate device meant only for use when cleaning the aer basin.It is unknown who configured the connectors onto the aer, and it was observed that the connectors from the rv111100 were missing.It is unknown if there was any impact to any patient or other person, however, no death or injury has been reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Two serial numbers, (b)(6) and (b)(6) , were provided.The device history records associated with both of these serial numbers were received.A review of the device history records found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the reprocessing issue could not be determined.It is possible that the user did not read the instruction manual carefully and did not have equipment knowledge.There may have been a difference in recognition of device handling or reprocessing steps between olympus recommendation and the user facility.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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.Warning do not use the reprocessor if any connector seems to be damaged or defective.Using the reprocessor 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: 16075922
• MDR Text Key: 308529641
• Report Number: 9610595-2022-06319
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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: 07/20/2021
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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