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

Model Number OER-AW

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

An olympus employee reported on behalf of a customer, above the water tank of the endoscope reprocessor, black foreign matter kept getting caught in the filter.The event occurred during preparation for use.The unspecified diagnostic procedure was completed using a replacement device.There was no report of patient harm associated with this event.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.There was constant debris/foreign matter in the tank.In addition, the channel pump had an abnormal noise.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Event Description

The user facility confirmed the foreign material was deposited on various components, including the cleaning tanks, tubing for sanitizer inside the washer, water baths, mesh filters, etc.There was no apparent damaged in the oer or other equipment that may be related to the foreign material found.After various hoses were replaced, the foreign material no longer present and has not reappeared.The facility also confirmed no scopes were reprocessed in the oer with foreign material in it.After observing the foreign substances, the washer was discontinued and did not undergo endoscopic reprocessing.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer provided additional information, see b5.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus confirmed black foreign material was floating in disinfectant tank; however, it was unknown whether a hose inside the tank deteriorated or foreign material adhered to the hose peeled off.The reprocessing steps provided by the user were reviewed and there was no evident deviation from the instructions for use.Based on the results of the investigation, olympus could not identify what the foreign material was from the information obtained.A definitive root cause could not be determined.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: 17515955
• MDR Text Key: 321076261
• Report Number: 9610595-2023-11583
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

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-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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