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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

The olympus field service engineer, prior to performing preventative maintenance, noted the lcg usage indicator warning light on the front of the automated endoscope reprocessor (aer) which showed that the acecide disinfectant should have been changed 23 days prior, in accordance with the instructions for use.During that timeframe, the aer was used to reprocess multiple scopes, which were then used in various diagnostic esophagogastroduodenoscopy procedures (averaging 10 minute durations) / diagnostic colonoscopies (averaging 20 minute durations).The customer reported that the disinfectant has since been changed and all the scopes were properly reprocessed.The customer noted that all the times the aer's were used previously, the minimum effective disinfectant concentration check was performed and passed as positive (indicating that the chemical was intact to be used in the reprocessing of the scopes).All of the scopes passed the adenosine triphosphate test performed after coming out of the aer, and there were no traces of biofilm found as part of the customer's routine quality control.The customer reported that the endoscopy staff revised the proper way to care and reprocess the scope by the manufacturer recommendations and the hospital process protocol to ensure the compliance of all the steps and regulations for infection control, a new log indicating the mandatory change of the disinfectant every 5 days was established as part of the scope reprocessing protocol, and a new way to have enough supply of the scope washer was established.All of the patients involved were followed by the infection control practitioner at the customer site and there were no reports of infections, symptoms, medical interventions, procedure delays or procedure cancellations.Reports are being submitted on the oer-pro's and scopes that were reprocessed using the oer-pro's.Please refer to the following related patient identifiers: (b)(6).

Manufacturer Narrative

The endoscopy support specialist (ess) visited the site to provide a reprocessing in-service for the oer-pro and scopes.All of the endoscopy staff at the site were advised of the proper way to care for and reprocess the scopes in accordance with the ifus in order to avoid acquired infections to the patients.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.Updated fields: h6 and h10.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 user did not read the instructions for use (ifu) thoroughly.As a result, the event occurred by mismanagement of disinfectant replacement.The event can be detected and prevented by handling the device in accordance with the instructions for use which state: oer-pro operation manual.6.4 setting the disinfectant solution counter.Note on the disinfectant solution counter function.Acecide-c product overview.Reuse period up to 5 days.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: 18101887
• MDR Text Key: 327745381
• Report Number: 9610595-2023-16808
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: 10/11/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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