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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I. SCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I. SCOPE Back to Search Results
Model Number EG-290KP
Device Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  malfunction  
Manufacturer Narrative
This device is import for export, therefore 510k is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.
 
Event Description
Pentax medical was made aware of an issue that occurred in the apac region.The information provided indicated that during the pre-use routine inspection of the gastroscope, it was found that the position of the gastroscope's water nozzle was shifted, which did not cause adverse harm to the patient.The issue involved an (b)(4) video upper gi scope.It is unknown if the device was sent for inspection and repair.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.
 
Manufacturer Narrative
This device is import for export, therefore 510k is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.
 
Event Description
Pentax medical was made aware of an issue that occurred in the apac region.The information provided indicated that during the pre-use routine inspection of the gastroscope, it was found that the position of the gastroscope's water nozzle was shifted, which did not cause adverse harm to the patient.The issue involved an eg-290kp video upper gi scope.It is unknown if the device was sent for inspection and repair.
 
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Brand Name
PENTAX
Type of Device
VIDEO UPPER G.I. SCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12712057
MDR Text Key285240444
Report Number9610877-2021-00462
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,foreig
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG-290KP
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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