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

Model Number	VNL8-J10
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to the loosened scope sleeve.In addition, we confirmed that angle lever trim cap missing, the remote control button(4) rapture.The distal body with lcb had been broken, however, these are not related to the alleged complaint.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
This event occured before use.There was no report of patient harm.Delivery date: august 21, 2019.On (b)(6) 2021, i had visited after being informed that the light intensity of the scope was dark.Confirmed in the presence of dr.But the darkness was not reproduced.Tightening is performed due to looseness of the scope sleeve.Compared to the substitute, but no particular darkness is felt.It is said that it became brighter by tightening the sleeve.Processor confirmation (no error code) just in case.Have a look at the situation at this time.On (b)(6) 2021, i was informed by the facility that the amount of light was dark, so i replaced it with a substitute.

• Brand Name: PENTAX
• Common Device Name: VIDEO NASO PHARYNGO LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• MDR Report Key: 12285955
• Report Number: 9610877-2021-10330
• Device Sequence Number: 3165427
• Product Code: EOB
• UDI-Device Identifier: 04961333225354
• UDI-Public: 04961333225354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: VNL8-J10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1