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

Model Number OER-6

Device Problem Device Reprocessing Problem (1091)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The customer reported to olympus, after cleaning a videoscope with the olympus endoscope reprocessor, disinfecting alcohol, flushing, and wiping off, white deposits will appear on the insertion site after a while.It was also noted, the user attempted to change detergent, however, the issue was not resolved.There was no harm or user injury reported due to the event.Patient identifier (b)(6) captures the complaint on the evis lucera elite gastrointestinal videoscope model number: gif-h290, serial number: (b)(4).

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.

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 white deposit could not be determined.It is possible that the material adhesion may have been caused by insufficient rinsing of chemical agent or the accumulation of remnants.It is possible that the foreign material is a mixture of stearic acid calcium and organic silicon.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿immediately after each patient examination, perform bedside precleaning, clean the outer surfaces of the endoscope, brush the suction channel and around the forceps elevator, clean the valves, flush and rinse all channels according to the step-by-step cleaning procedure described in the endoscope¿s reprocessing manual.Complete both the prescribed bedside and manual cleaning procedures.After the endoscope undergoes full manual cleaning, it can be reprocessed in the oer-6.The oer-6 then provides supplemental cleaning and high-level disinfection.·always preclean each endoscope immediately after the examination.If precleaning is not executed promptly, debris will solidify and may prevent effective reprocessing.·if the endoscope is extremely dirty or precleaning was not practiced immediately after the examination, clean the endoscope in the method which is described in ¿cleaning when there is extreme debris, or when cleaning failed to be performed immediately after the examination¿ in the instruction manual of the endoscope.It may result in insufficient reprocessing of the endoscope or debris accumulating in the endoscope, preventing the endoscope from working correctly.¿ olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS 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: 16777809
• MDR Text Key: 313671140
• Report Number: 9610595-2023-06412
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/29/2023
• Supplement Dates FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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
• Treatment: MODEL NUMBER: GIF-H290 NO SERIAL NUMBER: (B)(6).