MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO FIBERSCOPE; RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-GP2
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An endoscopy support specialist (ess) was performing an in-service at the customer facility and discovered an inappropriate reprocessing routine related with the rhino-laryngo fiberscop.There was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
An endoscopy support specialist (ess) was performing an in-service at the customer facility and discovered an inappropriate reprocessing routine.The customer mentioned that the scope was utilized for approximately six weeks.After the procedure, the customer would rinse the scope off in the sink with cold water, wipe with alcohol swab, carry it to the reprocessing room, and solely placed the insertion tube in high-level disinfection to soak.Afterwards, the customer removed the scope from the high disinfectant to wiped with alcohol swab and it was stored in boxes received from olympus.The ess provided the customer with a reprocessing instruction for use (ifu) according to the olympus ifu.The root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to d9.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the device being incorrectly reprocessed was unable to be identified.The following is included in the instructions for use: ¿chapter 5 reprocessing the endoscope 5.5 manually cleaning the endoscope dry the external surfaces 1 dry the external surfaces of the endoscope by wiping with clean lint-free cloths.5.6 manually disinfecting the endoscope immerse the endoscope in disinfectant solution [warning] completely immerse the endoscope below the surface of the disinfectant solution so that all external surfaces of the endoscope contact the disinfectant solution.If the endoscope is not completely immersed, any protruding section(s) of the endoscope will not be adequately disinfected.Chapter 8 storage and disposal 8.1 precautions of storage and disposal [caution] store the endoscope and accessories in an endoscope storage cabinet that also protects the equipment from physical damage.¿ olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15929434
• Report Number: 3002808148-2022-04939
• Device Sequence Number: 6562837
• Product Code: EOB
• UDI-Device Identifier: 04953170399282
• UDI-Public: 04953170399282
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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-GP2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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
• Patient Sex: Unknown