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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL LINEAR ULTRASOUND SCOPE

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; DIGITAL LINEAR ULTRASOUND SCOPE Back to Search Results
Model Number EG38-J10UT
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2021
Event Type  malfunction  
Event Description
The time of event is unknown.There was no report of patient harm.Fiber image failure(fluid damage).
 
Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model eg38-j10ut-us is available in the usa with a 510k number k200090.We checked the returned unit and confirmed that the ccd driver pcb fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ccd driver pcb.In addition, we confirmed that the us connector body fluid damage, the lg cable connector fluid damage, and the us connector casing leakage; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
 
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Brand Name
PENTAX
Type of Device
DIGITAL LINEAR ULTRASOUND SCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-10
akishima-shi
tokyo, 196-0 012
JA  196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-10
akishima-shi
tokyo, 196-0 012
JA   196-0012
Manufacturer Contact
william
3 paragon drive
montvale
nj 07645
MDR Report Key13091455
MDR Text Key284833621
Report Number9610877-2021-51014
Device Sequence Number1
Product Code ODG
UDI-Device Identifier04961333239436
UDI-Public04961333239436
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG38-J10UT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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