MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO NASO PHARYNGO LARYNGOSCOPE

Model Number	VNL8-J10
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, but it's still under investigation,so the results of the investigation will be provided in a supplemental report.
Event or Problem Description
"the cloudiness of the image continues to be unclear, and the tip is cleaned, but it does not improve.If you use it for a long time, the cloudiness may be removed.Lt feels like there is water inside (no holes)" this event occurred at the time of during use.There was no report of patient harm.
Additional Manufacturer Narrative
Evaluation summary: we checked the returned unit and confirmed that the ccd module foggy.Based on the result, we concluded that it was caused due to the ccd module foggy.Correction information: g6: follow-up #1.H3: device evaluation.H6: coding changed based on the investigation result: component code.Additional information: h2: type of follow up.H6: coding added based on the investigation result: type of investigation, investigation findings, and investigation conclusions.This report is being filed as part of the pentax backlog management plan.

• Brand Name: PENTAX
• Common Device Name: VIDEO NASO PHARYNGO LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12114672
• Report Number: 9610877-2021-10043
• Device Sequence Number: 19918842
• Product Code: EOB
• UDI-Device Identifier: 04961333225354
• UDI-Public: 04961333225354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: VNL8-J10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/04/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1