MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO)

Model Number VNL9-CP

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

If any additional information is received, a supplemental report will be submitted.

Event Description

Pentax medical became aware of a report for an event which occurred in italy stating, "the instrument presents the image intermittent." involving pentax video ent scope model vnl9-cp/serial (b)(4).There was no report of death, serious injury or other significant/important medical event.No further information was provided at the time of the report.The device was returned to pentax medical italy service workshop where the following was confirmed: image disturbance, cmos assy defect.

• Brand Name: PENTAX
• Type of Device: VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12443181
• MDR Text Key: 283489988
• Report Number: 9610877-2021-00599
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• PMA/PMN Number: K171011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VNL9-CP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1