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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
Event Type  malfunction  
Event Description
The time of event is unknown.There was no report of patient harm.Video image failure.
 
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 module defective.Based on the result, we concluded that it was caused due to an excessive force applied.In addition, we confirmed the light guide fiber bundle (lcb) broken; however, other failures are not related to the alleged complaint.Based on the technical report, 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 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12670368
MDR Text Key284197918
Report Number9610877-2021-50116
Device Sequence Number1
Product Code ODG
UDI-Device Identifier04961333239436
UDI-Public04961333239436
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 10/21/2021
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
Device Operator Health Professional
Device Model NumberEG38-J10UT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2021
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received10/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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