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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE Back to Search Results
Model Number EG29-I10C
Device Problems Moisture Damage (1405); Optical Distortion (3000)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
This event occurred at the time of before use.There was no report of patient harm.There is a blurry / foggy image.There is moisture under the led cover glasses.This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c is available in the (b)(4) with a 510k number k131902.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 Description
This event occurred at the time of before use.There was no report of patient harm.There is a blurry / foggy image.There is moisture under the led cover glasses.
 
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Brand Name
PENTAX
Type of Device
IMAGINA GASTROSCOPE
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 07645
8004315880
MDR Report Key12194398
MDR Text Key262420335
Report Number9610877-2021-10407
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04961333248483
UDI-Public04961333248483
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/20/2021
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
Device Operator Health Professional
Device Model NumberEG29-I10C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/18/2021
Initial Date FDA Received07/20/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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