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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 No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Event Description
The time of event is unknown.There was no report of patient harm.Video image failure(blackout ).
 
Manufacturer Narrative
The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd module with drive pcb blackout.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module with drive pcb.In addition, our technician confirmed that the remote control buttons cracked, the operation channel (primary) leak, the ccd drive pcb loose, and the suction channel kink; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" 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 1-1-110
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
gurvinder nanda
3 paragon drive
montvale, NJ 07645
2015712318
MDR Report Key18956867
MDR Text Key338711063
Report Number9610877-2024-52380
Device Sequence Number1
Product Code ODG
UDI-Device Identifier04961333239436
UDI-Public04961333239436
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
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 Manufacturer03/07/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2024
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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