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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-I10
Device Problem Poor Quality Image (1408)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Pentax medical was made aware of a complaint that occurred in the united states.The customer reported poor illumination on video image involving pentax medical video gastroscope, model eg29-i10 (b)(4).The event timing and location are unknown.No death or serious injury was reported.
 
Manufacturer Narrative
(b)(4).The endoscope will be evaluated by pentax medical.Once evaluation is completed the device will be repaired and returned to the customer or loaner inventory as applicable.Model eg29-i10 (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 09-feb-2022, a device history record (dhr) review for model eg29-i10 (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 17-jan-2017 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 17-jan-2017.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
 
Manufacturer Narrative
Evaluation summary: we checked the returned unit and confirmed that the mecha base plate broken.Based on the result, we concluded that it was caused due to the excessive force applied on the mecha base plate.
 
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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 (temporary)
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key13519367
MDR Text Key296319223
Report Number9610877-2022-00246
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04961333211692
UDI-Public04961333211692
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/29/2022
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-I10
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/14/2022
Initial Date FDA Received02/13/2022
Supplement Dates Manufacturer Received01/14/2022
Supplement Dates FDA Received08/29/2022
Date Device Manufactured01/17/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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