MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO ENT SCOPE

Model Number VNL-90S

Device Problems Overheating of Device (1437); Unintended Movement (3026)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

(b)(6) 2021, confirmed that the image was not displayed when inspecting the equipment, and there was a little noise.The tip generates heat from the curved tip.No major trauma or leaks.This event occurred at the time of before delivery.There was no report of patient harm.

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.This device is not marketed in us, therefore 510k is not applicable.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed the ccd module as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the impurities is attached to the bending rubber , and the impurities or filth is attached to the insertion flexible tube (ift); 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.Correction information: type of report: follow up #1.Additional information: device manufacture date.

• Brand Name: PENTAX
• Type of Device: VIDEO ENT SCOPE
• 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: 13023290
• MDR Text Key: 286960335
• Report Number: 9610877-2021-01865
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VNL-90S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1