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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 Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
This device is not distributed in us so that 510k# is blank.The device was returned, but it's still under investigation,so the results of the investigation will be provided in a supplemental report.
 
Event Description
This event occurred at the time of before use.There was no report of patient harm.The a/w soccet at lg plug is loosened and leaky.
 
Manufacturer Narrative
Evaluation summary: we checked the returned unit and confirmed that the lg cable connector housing a-c0002 leak.Based on the result, we concluded that it was caused due to an excessive force applied on the lg cable connector housing a-c0002.This report is being filed as part of the pentax backlog management plan.
 
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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
MDR Report Key12114668
MDR Text Key264092749
Report Number9610877-2021-10044
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04961333248483
UDI-Public04961333248483
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2021
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
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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