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

Model Number VNL9-CP

Device Problems Optical Discoloration (2999); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The time of event is unknown.There was no report of patient harm.Bad image - rainbow effect, colored.Evaluation summary it was caused due to a physical damage applied on the body cover grip.This report is being filed as part of the pentax backlog management plan.

Event Description

The time of event is unknown.There was no report of patient harm.Bad image - rainbow effect, colored.

• 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
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale 07645 ; 8004315880
• MDR Report Key: 12194423
• MDR Text Key: 263396710
• Report Number: 9610877-2021-10604
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333239795
• UDI-Public: 04961333239795
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K171011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1