MAUDE Adverse Event Report: RHINO-LARYNGO VIDEOSCOPE

Model Number	ENF-VH2
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, no detailed information was available on the scope or cleanse at the facility so we could not identify the cause of the phenomenon.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Advanced sterilization products (asp) reported following information: the olympus enf-vh2 scope was inside a "pouch" and then the "pouch" is inside of a sterilization "tray" for sterilization process with an unknown asp brand version endoscope reprocessor.Upon completion of the sterilization, the user discovered the enf-vh2 scope had "bled" components as possible translation of melted scope components within.There was no harm or user injury reported due to the event.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Common Device Name: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15359233
• Report Number: 3002808148-2022-01712
• Device Sequence Number: 17466206
• Product Code: EOB
• UDI-Device Identifier: 04953170411427
• UDI-Public: 04953170411427
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K182102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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-VH2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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