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

Model Number OER-ELITE

Device Problem Difficult to Open or Close (2921)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the automated endoscope reprocessor had the lid pop open during cycle.Olympus service performed an evaluation at customer's site.During evaluation, the device was found to have a scope setting/lid problem.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No patient involvement reported.

Manufacturer Narrative

During field service, the technician adjusted the reprocessor lid.After adjustment, the open/close function worked as expected.The device passed all functional tests.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

Updated: d8, h3, h6, h10 this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided, however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause of the oer lid opening during reprocessing could not be determined, however, it is likely that the lid hook/latch was shifted by an accidental impact or vibration, causing the lid half open.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: 18340989
• MDR Text Key: 330969732
• Report Number: 9610595-2023-19707
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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: 12/04/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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