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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA COLONOSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA COLONOSCOPE Back to Search Results
Model Number EC34-I10CL
Medical Device Problem Code Erratic or Intermittent Display (1182)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to fluid damage in the lg cable connector assy and the control body assy complete through the channel.The air water channel was related to the allege complaint.This device is classified as import for export, therefore 510k is not applicable.Model ec34-i10cl-us is available in the usa with a 510k number k190805.This report is being filed as part of the pentax backlog management plan.
 
Event or Problem Description
The time of event is unknown.There was no report of patient harm.3 dots appeared on the lens at 4 o'clock location.
 
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Brand Name
PENTAX
Common Device Name
IMAGINA COLONOSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12200867
Report Number9610877-2021-10662
Device Sequence Number17237387
Product Code FDF
UDI-Device Identifier04961333248711
UDI-Public04961333248711
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
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 NumberEC34-I10CL
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/13/2021
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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