MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO VIDEOSCOPE

Model Number	ENF-VT2
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record confirmed that the device met its standards at the time of shipment.It has been over 7 years since the subject device was manufactured.Since the subject device was not returned, investigation was carried out based on the available information.Although the investigation found the scope was reprocessed on the oer-4 with potential failures of the harness on the fluid flushing pump being broken, or a high voltage that was temporarily applied to the motor of the pump; a definitive root cause of the reprocessing of the scope could not be confirmed.Olympus will continue to monitor field performance for this device.Supplemental report(s) will be submitted should any relevant new information is available and or received.
Event or Problem Description
The customer reported to olympus that when reprocessing the rhino-laryngo videoscope, the oer-4 reprocessor liquid transfer pump malfunctioned.It was also reported that the scope was possibly washed in bad condition and used on a patient.There was a therapeutic procedure completed using the same set of equipment.There were no reports of patient harm.Related patient identifiers: (b)(6).

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Common Device Name: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17114847
• Report Number: 3002808148-2023-05870
• Device Sequence Number: 12410572
• Product Code: EOB
• UDI-Device Identifier: 04953170339509
• UDI-Public: 04953170339509
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: ENF-VT2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OER-4 ENDOSCOPE REPROCESSOR SN: (B)(6)
• Patient Sex: Unknown