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

Model Number VNL8-J10

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 11/11/2021

Event Type  malfunction  

Event Description

Noise and blackout occur when the angle is applied during use.This happens especially when you put up.No trauma can be confirmed at the insertion part, and there is no leak.There is no health hazard to patients, medical staff, etc.Due to the above failure situation.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the h1 signal in the flexible printed board of the ccd module as conduction failure.Based on the result, we concluded that it was caused due to too more usage of repeated angulation than estimated lifetime.Therefore, h1 signal in the flexible printed board got damaged by the tension of ccd cable ,when the endoscope angulation function was used.Correction information: g6: follow up #1.H6: coding changed based on the investigation result.

• Brand Name: PENTAX
• Type of Device: VIDEO NASO PHARYNGO LARYNGOSCOPE
• 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: 12824806
• MDR Text Key: 282386893
• Report Number: 9610877-2021-01610
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172156
• 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,Followup
• Report Date: 05/10/2022

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
• Device Operator: Health Professional
• Device Model Number: VNL8-J10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1