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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO NASO PHARYNGO LARYNGOSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO NASO PHARYNGO LARYNGOSCOPE Back to Search Results
Model Number VNL-1570STK
Medical Device Problem Codes Moisture Damage (1405); Optical Distortion (3000)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/12/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to a condensation of moisture in the ccd unit by changing the temperature outside of the endoscope.This report is being filed as part of the pentax backlog management plan.
 
Event or Problem Description
This event occurred at the time of during use.There was no report of patient harm.During use, the image became foggy suddenly.The user stopped using this scope and changed another one to complete.
 
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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 196-0 012
JA  196-0012
MDR Report Key12222450
Report Number9610877-2021-10295
Device Sequence Number4137034
Product Code EOB
UDI-Device Identifier04961333233809
UDI-Public04961333233809
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K162151
Number of Events Summarized1
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) 07/21/2021
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 NumberVNL-1570STK
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/12/2021
Initial Report FDA Received Date07/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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