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

Model Number VNL-1190STK

Device Problem Collapse (1099)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model vnl11-j10 is available in the usa with a 510k number k172156.We checked the returned unit and confirmed that the insertion flexible tube (ift) spiral closer condition.Based on the result, we concluded that it was caused due to the excessive force applied on the insertion flexible tube (ift).In addition, we confirmed that the u/d lock lever broken, the remote control buttons perforated, the insertion flexible tube (ift) buckled, the light guide cable buckled, the light guide cable for control body buckled, the light guide cable for prong buckled, the remote control buttons leak, the objective lens unit dirty, and the u/d knob white marking faded and missing; however, they are not the main cause, and/or irrelevant to the alleged complaint.As a result of confirming the detail as gfe, no response was obtained, so we can not deny the possibility of the angle stuck.Therefore, based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is unknown.There was no report of patient harm.Insertion flexible tube (ift) hardened.

• Brand Name: PENTAX
• Type of Device: VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
• 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: 14018945
• MDR Text Key: 298337921
• Report Number: 9610877-2022-52216
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333166787
• UDI-Public: 4961333166787
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• 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