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

Model Number OER-PRO

Device Problem Component Incompatible (1108)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, during reprocessing, the endoscope reprocessor exhibited error e93 indicating ¿no alcohol remains¿.During troubleshooting, it was noted, the customer was not using compatible connecting tube with the reprocessor.The customer also verified alcohol was present in the alcohol bottle.Additional information received indicating, the alcohol had air in line, once the air was out, the subject device worked.There was no harm or user injury reported due to the event.

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 is a supplemental report to correct the initial mdr.The initial medwatch reported an e93 error and the customer not using a compatible connecting tube with the reprocessor; however; 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: 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: 16530454
• MDR Text Key: 311568092
• Report Number: 9610595-2023-04180
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2015
• 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