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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
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
Event Type  malfunction  
Event Description
The user found the overall image was dark, which affected the doctor's judgment.The device was out of warranty period, and was delivered to manufacturer's engineer for processing.This event occurred at the time of during inspection.There was no report of patient harm.
 
Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
 
Manufacturer Narrative
Evaluation summary: the scope was repaired by the third party and returned to the hospital.The hospital was not available to provide detailed information.Reminded the hospital that the daily operation and reprocessing procedure of the endoscope should be regulated in accordance with the ifu, which can reduce the occurrence of accidents.Correction information: g6: follow up #1.H2: type of follow up.H4: device manufacture date.H6: coding changed based on the investigation result.
 
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Brand Name
PENTAX
Type of Device
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
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 Key12776127
MDR Text Key281520326
Report Number9610877-2021-01510
Device Sequence Number1
Product Code EOB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K162151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/02/2022
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 NumberVNL-1570STK
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2021
Initial Date FDA Received11/08/2021
Supplement Dates Manufacturer Received10/29/2021
Supplement Dates FDA Received02/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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