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

The device was not returned to olympus for evaluation.The customer performed troubleshooting; the customer put new internal water filter and loaded a new liquid chemical germicide (lcg), ran a disinfectant line and drained the lcg, cleaned the tank, tank sensor and basin using alcohol for 15 minutes, placed all scopes connecting tubes to the alcohol basin to remove the oil, and to isolate the dirty scopes and the customer was advised to send to olympus for validation.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 reported to olympus, the endoscope reprocessor had mineral oil throughout the unit.The customer put lubricant laxative oil on the scope when used with a stent for an unknown procedure, then pre-cleaned the scope and placed in the reprocessor (oer-pro) for reprocessing.The oil spread through both machines and the other scopes.The issue was found during reprocessing.There were no reports of patient injury or harm.

Manufacturer Narrative

This supplemental report is being submitted 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.The device was not returned to olympus for evaluation, however the customer's allegation was confirmed via phone support.Based on the results of the investigation, the user did not conduct precleaning properly, a lubricant was unable to be removed and then it spread inside reprocessor during reprocessing.However, since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The event can be detected and prevented by handling the device in accordance with the following sections of the instructions for use: 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 3) 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.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: 18436237
• MDR Text Key: 331881509
• Report Number: 9610595-2024-00127
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• 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
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2014
• 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