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

Model Number OER-PRO

Device Problem Flushing Problem (1252)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

A customer reported to olympus that alcohol was replaced with acetone in the endoscope reprocessor.Eight scopes were reprocessed but none were used on patients.The scopes were reprocessed correctly using alcohol.There was no report of patient harm associated with this event.

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.An olympus representative has instructed the customer to return the devices for evaluation, as acetone could possibly damage the scopes.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 root cause of the reported event is unable to be determined.However, the likely cause of the reported event is due to the possibility that the user did not read instructions for use (ifu) thoroughly.The event can be detected and prevented by following the ifu section which state: chapter 3.Inspection before use.3.6 inspecting and replenishing alcohol.Check how much alcohol is in the alcohol tank and add more as required.[warning] the alcohol used with the equipment must be 70% ethyl alcohol or isopropyl alcohol.Using any other kind of alcohol may result in malfunction of the equipment or the endoscope, difficulty drying the endoscope, fire hazard, or a hazard due to toxic vapor emitted from the alcohol.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: 18292057
• MDR Text Key: 330676387
• Report Number: 9610595-2023-19096
• Device Sequence Number: 1
• Product Code: FEB
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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
• Treatment: SN2612134 - GIF-XP190N GASTROINTESTINAL VIDEOSCOPE; SN2615562 ¿ PCF-H190DL COLONOVIDEOSCOPE; SN2746634 ¿ GIF-HQ190 GASTROINTESTINAL VIDEOSCOPE; SN2746740 - GIF-HQ190 GASTROINTESTINAL VIDEOSCOPE; SN2746759 ¿ GIF-HQ190 GASTROINTESTINAL VIDEOSCOPE; SN2746762 ¿ GIF-HQ190 GASTROINTESTINAL VIDEOSCOPE; SN2746764 ¿ GIF-HQ190 GASTROINTESTINAL VIDEOSCOPE; SN2746768 ¿ GIF-HQ190 GASTROINTESTINAL VIDEOSCOPE