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

Model Number VNL9-CP

Device Problem Poor Quality Image (1408)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Poor image quality.There was no report of patient harm.The time of event is unknown.Event date: not known for the exact date, we just know the year the complaint was sent in to manufacturer.

Manufacturer Narrative

During pentax internal review, the same event was filed under mdr (9610877-2022-52344) which was submitted.Therefore, mdr (9610877-2022-00303) filed on march 2, 2022 is considered a duplicate report.

• 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, NJ 07645 ; 8004315880
• MDR Report Key: 13657038
• MDR Text Key: 296680048
• Report Number: 9610877-2022-00303
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333239795
• UDI-Public: 04961333239795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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: 02/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1