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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 Codes Mechanical Problem (1384); Connection Problem (2900); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/17/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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.Evaluation summary: it was caused due to an excessive force applied on the cmos cable.
 
Event or Problem Description
The led light flickers even though it is switched off.It lights brighter during movement.A/w connector is loosened.This event occurred at the time of during inspection.There was no report of patient harm.
 
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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 Key12236962
Report Number9610877-2021-00325
Device Sequence Number19749915
Product Code FDF
UDI-Device Identifier04961333248711
UDI-Public04961333248711
Combination Product (Y/N)N
Initial Reporter CountrySZ
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/28/2021
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 07/01/2021
Initial Report FDA Received Date07/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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