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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO ESOPHAGOSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO ESOPHAGOSCOPE Back to Search Results
Model Number EE17-J10
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  malfunction  
Event Description
The time of event is not during procedure.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 ee-1580k is available in the usa with a 510k number k961564.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the image horizontal lines.Based on the result, we concluded that it was caused due to the excessive force applied on the image.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
VIDEO ESOPHAGOSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishisima-shi, tokyo 196-0 012
JA  196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishisima-shi, tokyo 196-0 012
JA   196-0012
Manufacturer Contact
william goeller
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key18213898
MDR Text Key329333208
Report Number9610877-2023-61271
Device Sequence Number1
Product Code GCL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2023
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 NumberEE17-J10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2023
Initial Date Manufacturer Received 11/14/2023
Initial Date FDA Received11/28/2023
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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