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

Model Number OER-3

Device Problem Contamination (1120)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has 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, after cleaning, the circulation port mesh filter of the olympus endoscope reprocessor had black foreign substance.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr.The initial medwatch reported the circulation port mesh filter of the subject device had black foreign substance; however; upon evaluation by the legal manufacturer it is likely the hose inside the subject device was used for many years which became fine and peeled off resulting in the black foreign matter.Customer confirmed the scope was manually cleaned.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 15879511
• MDR Text Key: 304778664
• Report Number: 9610595-2022-04612
• 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: 05/18/2023

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-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• 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