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

Model Number OER-6

Device Problem Contamination (1120)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of white foreign matter attached to the gas filter case was confirmed.The allegation of a broken clasp used to close the lid was confirmed due to damage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus employee reported on behalf of a customer, when the biomedical engineer tried to replace the gas filter of the endoscope reprocessor, the base of the lid for the gas filter case in washer tank broke and fell off.There were white crystals on the lid near the filter case of the washer.It is possible the crystals adhered to the gas filter case and caused it to break.Also, the clasp used to close the gas filter was broken.There was no report of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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, the reported foreign material/white crystals observed inside the gas filter case may have been derived from acecide and tap water.The white foreign substance observed near the gas filter case mount may have been derived from silicic acid (possibly derived from tap water or chemicals).A definitive root cause of the issue could not be determined, however, it is possible that water droplets were left on the surface since the user only cleaned the external surface of the device.It was confirmed that the cleaning of the outer surfaces of the equipment was not performed as per the ifu.Additionally, a definitive root case of the damaged clasp of the gas filter case lid could not be determined, however, the clasp fracture surface was characteristic of a brittle fracture, indicating that it was a solvent crack (fracture caused by the interaction of stress and chemicals) and some kind of impact.It is possible that the gas filter case lid clasp was damaged due to a combination of factors.It is possible that the gas filter case clamps may have been damaged when refilling the aseside or endo quick, as they hang on the clasp of the gas filter case, and that the failure to clean the outer surfaces of the device may have resulted in residual chemicals and cracking.In addition, it is possible that the gas filter case clasp was damaged by the force exerted on it when the gas filter case clasp was removed in this state.The event can be detected/prevented by following the instructions for use which states: chapter 5 end-of-day checks.5.4 turning the power off, closing the water faucet, and cleaning the outer surface of equipment.3 using a clean cloth moistened with neutral detergent solution, clean every part of the equipment including the front and back of the lid, the lid packing, the edge and inside of the reprocessing basin, and the control panel, then wipe with a dry clean cloth.To prevent growth of various germs, it is also recommended to wipe every part of the equipment with a cloth moistened with 70% ethyl alcohol or 70% isopropyl alcohol.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: 17826254
• MDR Text Key: 324377081
• Report Number: 9610595-2023-14151
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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