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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE - I10 STANDARD

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE - I10 STANDARD Back to Search Results
Model Number EG29-I10N
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
This device is not distributed in us so that unique identifier is blank.This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10 is available in the usa with a 510k number k131902.Since there are no defective parts,the medical device problem code,investigation findings are blank.Evaluation summary: it was caused due to the design specification depending on the customer's preference.It is not the product failure.This report is being filed as part of the pentax backlog management plan.
 
Event Description
This event occurred at the time of during use.There was no report of patient harm.The position of the button 1 is too high; the user is easy to press not straightly and cause the button transformed and malfunction of the button.
 
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Brand Name
PENTAX
Type of Device
VIDEO GASTROSCOPE - I10 STANDARD
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA   196-0012
Manufacturer Contact
william goeller
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key12236989
MDR Text Key266079750
Report Number9610877-2021-10698
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG29-I10N
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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