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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE Back to Search Results
Model Number EG29-I10C
Device Problem Poor Quality Image (1408)
Patient Problem Insufficient Information (4580)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.There is a similar model eg29-i10c-us available for sale in the united states with a 510k #k190805.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
 
Event Description
Pentax medical was made aware of an event which occurred in the asia pacific region involving pentax video scope eg29-i10c.In the event reported, it was stated that the image was foggy.The anomaly was observed in the operation room before use.There was no adverse event reported with this complaint.No additional information was provided this complaint.
 
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Brand Name
PENTAX
Type of Device
VIDEO GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0012
JA 
MDR Report Key12396072
MDR Text Key283249055
Report Number9610877-2021-00593
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 08/31/2021
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 NumberEG29-I10C
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/02/2021
Initial Date FDA Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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