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

Model Number OER-PRO

Device Problem Device Difficult to Maintain (3134)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.The investigation is ongoing.And a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus technical assistance center (tac), the endoscope reprocessor had sat for about a year, and needed to be brought back online.It was noted ,that it is unknown, if the proper methods were used to store it.There was no patient involvement in this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the storing method issue could not be determined.It is unknown if the appropriate storing method was used.It is possible that the user did not read the instruction manual carefully and did not have the equipment knowledge.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿when the equipment will be stored for more than 14 days, follow the procedure described in this section.¿ 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: 16744040
• MDR Text Key: 313351072
• Report Number: 9610595-2023-06150
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• 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: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2010
• 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