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

Model Number VNL8-J10

Device Problem Component Missing (2306)

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

Event Date 03/04/2022

Event Type  malfunction  

Event Description

The time of event is unknown.There was no report of patient harm.Bending rubber adhesive falls off.

Manufacturer Narrative

We checked the returned unit and confirmed that the bending rubber gluing missing.Based on the result, we concluded that it was caused due to the physical damage applied on the bending rubber gluing.In addition, we confirmed that the insertion flexible tube (ift) coating damage, the light guide fiber bundle (lcb) broken, the bending rubber dirty, the insertion flexible tube (ift) dirty, and the objective lens unit dirty; however, they are not the main cause, and/or irrelevant to the alleged complaint.As a result of gfe, it was not possible to identify where the bending rubber gluing fell, so it was evaluated to submit the mdr based on technical reports and risk analysis results.

• Brand Name: PENTAX
• Type of Device: VIDEO NASO PHARYNGO LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 13926019
• MDR Text Key: 297869414
• Report Number: 9610877-2022-51997
• 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
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1