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

Model Number VNL-1190STK

Device Problem Poor Quality Image (1408)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.(b)(4).The endoscope will be evaluated by pentax medical.Once evaluation is completed the device will be repaired and returned to the customer or loaner inventory as applicable.Model vnl-1190stk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 07-feb-2022, a device history record(dhr) review for model vnl-1190stk, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the miyagi facility on 29-jul-2011 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 29-jul-2011.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint that occurred in the united states.The customer reported poor image quality involving pentax medical video naso pharyngo laryngostoboscope, model vnl-1190stk, serial number (b)(4).The event timing and location are unknown.No death or serious injury was reported.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

Evaluation summary: regarding this event, it was confirmed from the repair history that the light distribution lens had been replaced.Therefore, it is presumed that the observation was difficult due to the irregularity of the illumination caused by the abnormality in the light distribution lens.Correction information: g4: premarket identification pma/510(k) 510k number is unknown.H6: coding changed based on the investigation result.Additional information: h3: device evaluated.

• Brand Name: PENTAX
• Type of Device: VIDEO NASO PHARYNGO LARYNGOSTOBOSCOPE
• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13519200
• MDR Text Key: 296319682
• Report Number: 9610877-2022-00205
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VNL-1190STK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1