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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE Back to Search Results
Model Number EG29-I10C
Device Problems Moisture Damage (1405); Optical Distortion (3000)
Patient Problem Insufficient Information (4580)
Event Date 06/14/2021
Event Type  malfunction  
Event Description
Pentax medical was made aware of a complaint on (b)(6) 2021 for "moisture in the lens, foggy image in the middle of the image" that occurred in the operating room, prior to use in the (b)(6) region involving pentax medical video gastroscope, model eg29-i10c, serial number (b)(4).The information provided indicated that there was no leak.The endoscope has since been inspected at the pmk service center and the customer complaint confirmed.The endoscope is currently awaiting repairs.This event meets the requirements for fda reportability.
 
Manufacturer Narrative
Import for export.(b)(4).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
IMAGINA GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12166726
MDR Text Key280570761
Report Number9610877-2021-00203
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 07/14/2021
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 06/14/2021
Initial Date FDA Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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