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 Type  malfunction  

Manufacturer Narrative

Olympus representative from technical assistant center (tac) recommended not to reprocess any more scopes with the unit until someone goes out to make sure there is no oil in any parts of the unit which could potentially harbor bacteria from the previous procedure.Customer was also advised by tac to send the endoscopes to olympus to check for any damage.Olympus field service engineer (fse) had provided onsite service for endoscope reprocessor (oer) at user facility.According to fse, user put lubricant laxative oil on scope when using with stent for procedure, then pre-clean scope and put the scope into the oer for reprocessing.The oil spread to both machines and spread to the other scopes.Fse performed following steps: drained the disinfectant solution (lcg) and removed the internal filter.Refilled full tank with water and drained the water.Used the preventive maintenance software to fill the alcohol to the tank from the basin.Filled the full basin with alcohol from tank and used the software to run circulation flow within 15 minutes then drain all the alcohol.Refilled water to tank and drain again.Put new internal water filter and loaded new lcg.Ran a disinfectant line then drain the lcg.Used alcohol clean the tank, tank sensor and basin.Put all of scope connecting tubes to the alcohol basin to remove the oil.Customer was recommended to isolate the dirty scopes and send to olympus for validation.The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer contacted olympus to report that the surgeon used mineral oil on an endoscope to which the technician then proceeded to clean with dish soap and run through the endoscope reprocessor.Customer was wondering if there was any potential for the endoscope reprocessor to become damaged with any residual mineral oil or dish soap, and if there was a potential for the residual material to spread to other processed endoscopes.There were no reports on patient harm associated with the event.

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, a definitive root cause of the reported mineral oil lubricant used on the scope may have spread to oer during reprocessing issue could not be determined, however, it is possible that the lubricant could not be removed because the user did not perform pre-cleaning properly, and the lubricant spread inside the oer during cleaning.The event can be detected/prevented by following the instructions for use which state: chapter 4 reprocessing operations before using this equipment for the first time, full setup is required including installing accessories, connecting power and water supplies and disinfecting the equipment¿s internal piping.Refer to instructions-installation manual for details.When it has not been used for more than 14 days, refer to section 7.18, ¿care and maintenance after long-term storage¿ on page 272.Be sure to perform the preliminary checks before reprocessing endoscopes with this equipment.Otherwise, the equipment may not function at optimal levels.See chapter 3, ¿inspection before use¿ for details on the preliminary checks and chapter 5, ¿end-of-day checks¿ for details on the final checks at the end of the day.Endoscopes must be first cleaned according to one of two ways, prior to reprocessing in the oer-pro: manual precleaning and cleaning.Immediately after each patient examination, perform bedside cleaning, clean the outer surfaces of the endoscope, brush the forceps elevator (if applicable), brush the suction channel, flush and rinse all channels according to the step-by-step cleaning procedure described in the endoscope¿s instruction manual.Complete both the prescribed bedside and manual cleaning procedures.After the endoscope undergoes full manual cleaning, it can be reprocessed in the oer-pro.The oer-pro then provides supplemental cleaning and high-level disinfection.Modified precleaning and cleaning.Immediately after each patient examination, perform the bedside-cleaning and manual-cleaning procedures for the endoscope as described in the endoscope¿s instruction manual, but with the modifications described in section 4.3, ¿endoscope precleaning and manual cleaning¿ on page 79.This section describes: 1) how certain steps performed at the bedside can be performed using less fluid volume, and using water in place of detergent, 2) how the manual steps for brushing the channels and the elevator (if applicable), and for cleaning the outside surfaces of the endoscope are unchanged, but how the requirement to connect certain flushing tubes, and the need to manually flush detergent and rinse water through the channels can be omitted.The functions of the modified/omitted steps are covered by the cleaning process of the oer-pro.After cleaning the endoscope following this modified procedure, the endoscope can be placed in the oer-pro.The oer-pro completes.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: 18406533
• MDR Text Key: 331502759
• Report Number: 9610595-2023-20416
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2013
• 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