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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2022

Event Type  Injury  

Event Description

The customer reported to olympus, during an unspecified therapeutic procedure, when the forceps were pushed through the scope channel, debris fell out into the patient.The debris appeared to be tissue from an unknown prior procedure.The debris was unable to be retrieved.The patient passed all unspecified tests and was not effected.The olympus field service engineer assessed the oer-pro and reported: performance test passed, channel pressure test passed, cycle test passed, checklist passed, tested good and placed machine back in service.This event includes 2 reports: (b)(6) : gif-h190, 2200391, (b)(6) : oer-pro, 2632752.This report is 2 of 2 for (b)(6) : oer-pro, 2632752.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The olympus field service engineer went onsite and evaluated the device.The device was within normal limits.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the event occurred because all the foreign material in the channel was not removed during manual cleaning.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿reprocessing operations.Endoscope precleaning and manual cleaning.Always preclean each endoscope immediately after the examination.If precleaning is not executed promptly, debris will solidify and may prevent effective reprocessing.Failure to pre-clean will leave excessive amounts of debris adhering to the endoscope and may compromise the effectiveness of the reprocessing.It may also result in debris accumulating in the endoscope, preventing the endoscope from working correctly.¿ this supplemental report includes new information received from the customer that was not previously submitted.B5 updated accordingly.A correction has been made to h3 and h6 (type of investigation) from the initial medwatch.H3 has been corrected to ¿no.¿ h6 code ¿10¿ (testing of actual/suspected device) was inadvertently selected on initial medwatch.Corrected codes have been added to h6 (type of investigation).Also, information has been added to d8.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received: it was reported that the scope was properly precleaned at the bedside sink.The user reported following the proper reprocessing steps based on the oer instruction manual.The water filter was replaced, and routine maintenance was performed by the user according to the manual instructions.The field service engineer (fse) reviewed the required steps to perform a water line disinfection during a call with the user.The user did not use expired disinfection.The user reported that the device is used daily and never stored long-term.The lid and each door are closed at the end of each day.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15709818
• MDR Text Key: 302826940
• Report Number: 9610595-2022-03544
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2016
• 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: GIF-H190, 2200391
• Patient Outcome(s): Other