Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE Back to Search Results
Model Number EG29-I10C
Medical Device Problem Codes Electrical /Electronic Property Problem (1198); Optical Distortion (3000); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/22/2021
Type of Reportable Event Malfunction
Event or Problem Description
This event occurred at the time of before use.There was no report of patient harm.Iso failed, misty image, led cover glass broken.
 
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c is available in the usa with a 510k number k190805.Evaluation summary: we checked the returned product and confirmed that it was caused due to a leak at the led cover glass by a physical damage.Due to the leak,it caused that the electrical safety test in emea to fail.This report is being filed as part of the pentax backlog management plan.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PENTAX
Common Device Name
IMAGINA GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12351824
Report Number9610877-2021-10534
Device Sequence Number17458181
Product Code FDS
UDI-Device Identifier04961333248483
UDI-Public04961333248483
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 08/21/2021
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 NumberEG29-I10C
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/22/2021
Initial Report FDA Received Date08/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-