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)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 establishment name: (b)(6) hospital.During device evaluation at olympus, it was found the complaint was confirmed and water tightness was lost due to a pinhole on the instrument tube.Also, evaluation found no electrical continuity due to corrosion on the distal end, the bending section cover adhesive was chipped, the connecting tube was dented, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, the control unit was sticky due to water leakage, and multiple parts of the scope were scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported the rhino-laryngo videoscope had green water coming out of the forceps mouth.The customer noted the scope leaked when being dried after washing.The issue was found when preparing the scope for use in a therapeutic procedure.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The e1 "telephone number" was corrected based on information available at the initial report submission.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely that a leak failure occurred due to a pinhole on the forceps channel.Thus, reprocessing could not be completed and green water remained.However, a definitive root cause could not be established.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: chapter 4 reprocessing work flow for endoscopes and accessories; chapter 5 reprocessing of endoscopes (and accessories reprocessed together).Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3002808148.

• 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: 17171033
• Report Number: 9610595-2023-09098
• Device Sequence Number: 20486032
• Product Code: EOB
• UDI-Device Identifier: 04953170399640
• UDI-Public: 04953170399640
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2024

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-VT3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 06/25/2023; 05/13/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/20/2023; 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2018
• 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