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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE Back to Search Results
Model Number EG-290KP
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/08/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model eg-2990k is available in the usa with a 510k number k131902.Evaluation summary it was caused due to a fluid damage in 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 inspection.There was no report of patient harm.During daily inspection the user found that the scope was leaking.
 
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Brand Name
PENTAX
Common Device Name
VIDEO GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12200831
Report Number9610877-2021-10193
Device Sequence Number14563094
Product Code FDS
UDI-Device Identifier04961333224913
UDI-Public04961333224913
Combination Product (Y/N)N
Initial Reporter CountryCH
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
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 NumberEG-290KP
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2021
Initial Report FDA Received Date07/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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