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

Model Number	VNL8-J10
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to an excessive force applied on the ccd cable.In addition, we confirmed that insertion flex tube w/segment degradation, the remote control button(1) malfunction, however, these are not related to the alleged complaint.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
When i checked the endoscopic image before using the test, there was noise (blackout) in the image.(always occur).In addition, since defects were confirmed in the pre-use inspection, no health damage has occurred to patients or healthcare professionals.

• 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 19600 12; JA 1960012
• MDR Report Key: 12278848
• Report Number: 9610877-2021-10327
• Device Sequence Number: 14803462
• 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
• Report Date (Section B): 08/05/2021

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: 04/05/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1