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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE Back to Search Results
Model Number EG-2990I
Device Problem Decrease in Suction (1146)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
Pentax medical became aware of a report for an event which occurred in the usa stating, "low suction" involving pentax model eg-2990i/serial (b)(4).No further information was provided at the time of the report.The device was returned to pentax.Pentax service inspectional findings included: leak at biopsy channel (large/ primary) inlet side, failed dry leak test, failed wet leak test, primary operation channel resistance, air/ water socket o-ring chipped, umbilical cable bump at control body side, umbilical cable bump under pve root brace.Repairs were performed on the device which included replacement of the following components: o-rings and seals, distal end assy with tubes, adjusting collar, bending rubber, angle wire, rl pulley assy, ud pulley assy.The device was shipped back to the facility on 07/15/2021.
 
Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
 
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Brand Name
PENTAX
Type of Device
HD VIDEO GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12355728
MDR Text Key283152285
Report Number9610877-2021-00777
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04961333129492
UDI-Public04961333129492
Combination Product (y/n)N
PMA/PMN Number
K131902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG-2990I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Date Manufacturer Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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