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

Model Number OER-ELITE

Device Problem Mechanical Problem (1384)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

The customer reported the endoscope reprocessor had disinfectant (acecide-c) cassettes that were bowed.The customer reported they noticed the bottle issue during reprocessing.The user placed the disinfectant cassette back in the reprocessor and tried to close the disinfectant bottle drawer and open it again.The customer reported the locking mechanism may be damaged.During the original telephone call with customer, olympus field service attempted to guide the customer through the lcg (disinfectant) draining process as per the instruction manual.The customer contact reported the device would not let them do this because there was no disinfectant in the tank.No patient involvement reported.

Manufacturer Narrative

In speaking with olympus technical assistance center (tac), the customer requested an eta for service because "both preprocessors were down" and they needed "to know if they need to cancel cases for tomorrow".That same day, an olympus field service engineer (fse) had a videoconference call with the customer's gastrointestinal technicians (gi tech) for device troubleshooting.The fse did not find evidence of deformity during examination of the cassette drawer or other components.The fse also found no components that were broken or detached.The gi techs were led through the load process with a new set of acecide-c bottles.The load process was completed as directed.The tray operation was smooth and no error messages occurred.The reprocessor was used for a full reprocessing cycle which was successfully completed.During the videoconference, no device problems were identified and the device was found functional.The reported issue was resolved with customer, therefore the device was not returned to olympus for the evaluation of the reported event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over two years since the subject device was manufactured.The investigation determined that the acecide-c bottle packaging was likely transported and/or stored on its side rather than upright, which caused inflation or bulging of the bottle.The acecide-c bottle has a vented cap that relieves pressure from the acid solution; if the vented cap is covered, this may cause bulging or leakage.However, the root cause of the event could not be specified conclusively.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18034384
• MDR Text Key: 326968896
• Report Number: 9610595-2023-16119
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2023

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-ELITE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0638-2022
• Patient Sequence Number: 1
• Treatment: ACECIDE-C ELITE BOTTLE.