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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL RADIAL ULTRASOUND SCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL RADIAL ULTRASOUND SCOPE Back to Search Results
Model Number EG36-J10UR
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Manufacturer Narrative
This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.
 
Event Description
There is penetration of liquid in us socket.Parasites in the image.Reprocessing personnel perform leak tests.There are two olympus and two wassenburg aer's.The customer asks if the problem doesn't come from the oe-u4, because they don't have flood issues with ur and utk series.This event occurred at the time of before use.There was no report of patient harm.
 
Event Description
There is penetration of liquid in us socket.Parasites in the image.Reprocessing personnel perform leak tests.There are two olympus and two wassenburg aer's.The customer asks if the problem doesn't come from the oe-u4, because they don't have flood issues with ur and utk series.This event occurred at the time of before use.There was no report of patient harm.
 
Manufacturer Narrative
This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.
 
Manufacturer Narrative
Correction information g6: follow up #1 h6: coding changed based on the investigation result it was repaired.If additional information becomes available, a supplemental report will be filed with the new information.
 
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Brand Name
PENTAX
Type of Device
DIGITAL RADIAL ULTRASOUND SCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA   196-0012
Manufacturer Contact
william goeller
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key12965812
MDR Text Key286018997
Report Number9610877-2021-01802
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG36-J10UR
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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