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 01/20/2022

Event Type  malfunction  

Event Description

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

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 teethe cfb flexible tube hardened.Based on the result, we concluded that it was caused due to overused.In addition, we confirmed that the insertion flexible tube (ift) crushed, the remote control buttons perforated, the remote control buttons leaky, and the u/d lock lever cracked ; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.

• 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: 13435784
• MDR Text Key: 295873050
• Report Number: 9610877-2022-50421
• Device Sequence Number: 1
• Product Code: EOB
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2022

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: VNL-1190STK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/03/2022
• 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