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

Model Number	ENF-VT3
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the up/down angle operation was not possible on the rhino-laryngo videoscope.Upon inspecting and testing of the returned device, foreign material was detected inside of the instrument channel.Additionally, the customer reported the scope was cleaned, disinfected, and sterilized prior to being returned to olympus.The customer was unaware of a foreign object inside the instrument channel of the scope.There was no delay in pre-cleaning after clinical use.No abnormalities in the accessories for cleaning were observed.The instrument channel including ports of the scope were brushed and the facility uses another manufacturer¿s (unspecified) reprocessing machine.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem was confirmed.The device evaluation found foreign material inside the forceps channel.In addition, the device evaluation found there was an angle operation failure, the bending rubber glue was discolored, and the insertion tube was scratched.Dirt was found inside the instrument channel, objective lens was discolored, the switch 1 did not work and there was corrosion on the control unit.The device evaluation also found that there was watertightness failure of the forceps channel and there was a lead from the grip.Scratches were also found on the video connector and video connector case.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.The concerned product has not been repaired in the past year.Judging from the following facts found out from the investigation, it was surmised that the foreign material could not be removed due to physical damage of the device even though reprocessing was performed properly.Per the instruction manual (revision 3) it was determined that the reported phenomena might be prevented by the following.Caution: if the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if no visible damage of the lens on the distal end of the endoscope can be found.In this case, stop using the endoscope, and contact olympus.Olympus will continue to monitor the field performance of this device.

• 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: 17005153
• Report Number: 3002808148-2023-05303
• Device Sequence Number: 15098046
• Product Code: EOB
• UDI-Device Identifier: 04953170411526
• UDI-Public: 04953170411526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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-VT3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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