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

Model Number	ENF-VQ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1/establishment name: (b)(6) hospital.The device was returned to olympus for evaluation.In addition to the reported malfunction in b5, the following additional findings were as follows: water tightness was lost due to a cut on the connecting tube; the bending angle in the up direction did not meet the standard value due to wear of the angle wire; the control unit had corrosion due to water leakage; the label on the light guide connector was peeled; the video connector case had a scratch; the video connector had a scratch; the light guide connector had a scratch; the video cable had a dent; the video cable had a scratch; the forceps elevator lever had a scratch; the angulation lever had a scratch; the image guide protector had a scratch; the universal cord had coating peeling; the universal cord had a scratch; the up/down angulation lever plate had a scratch; the grip had a scratch; the switch box had a scratch; the suction cover had a scratch; the control unit had a scratch; the universal cord was sticky; the up/down angulation lever plate was sticky; the grip was sticky; the connecting tube had coating peeling; water tightness was lost due to a cut on the universal cord; the light guide bundle was slipping down; and switch one did not work due to corrosion.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported that the insertion part was scratched on the rhino-laryngo videoscope.There were no reports of patient harm due to the reported issue.The device was returned for evaluation.The device evaluation found that the plastic portion of the image guide snake tube fell off.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This supplemental report is being submitted 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.The device was returned to olympus for evaluation.The customer's allegation was confirmed.Based on the results of the investigation, the device likely malfunctioned due to physical or chemical stress.However, a definitive root cause could not be established.Olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18466226
• Report Number: 3002808148-2024-00250
• Device Sequence Number: 19604800
• Product Code: EOB
• UDI-Device Identifier: 04953170291050
• UDI-Public: 04953170291050
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2024

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-VQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2016
• 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