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 affected.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.Additional information 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.This event includes 2 reports: (b)(6) : gif-h190, (b)(6).(b)(6) : oer-pro, (b)(6).This report is 2 of 2 for (b)(6): oer-pro, (b)(6) the mfr medwatch report associated with this event was submitted on time under manufacturer report # 9610595 - 2022 - 03544.Upon review olympus is submitting the corresponding importer medwatch report.

• 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
• MDR Report Key: 17035621
• MDR Text Key: 316323117
• Report Number: 2429304-2023-00174
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/03/2022,05/31/2023

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?: Yes
• Distributor Facility Aware Date: 10/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other