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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 EG29-I10
Device Problems Device Contamination with Body Fluid (2317); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2022
Event Type  malfunction  
Manufacturer Narrative
If additional information becomes available, a supplemental report will be filed with the new information.
 
Event Description
Writer took a clean gastroscope from the cupboard and when sterile water was flushed through a dark colored fluid came out.Writer called in raymond (one of unit managers) and showed the fluid.This event occurred at the time of before use.There was no report of patient harm.
 
Manufacturer Narrative
Correction information: g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result.H4: device manufacture date.Evaluation summary: based on the contents of the report and the following confirmation results, it was assumed that the reprocessing process on the facility side was inadequate.Confirmation result: pentax medical checked the pipeline of the complained product that had dark colored water, but nothing was discharged and there was no abnormality in the pipeline.It is possible that the wastewater after reprocessing was stored in the cabinet in an insufficient state.
 
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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
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 Key15974514
MDR Text Key307980986
Report Number9610877-2022-00672
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04961333232536
UDI-Public04961333232536
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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