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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE Back to Search Results
Model Number EG27-I10
Device Problem Device Contaminated at the User Facility (4064)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Event Description
Pentax medical was made aware of an event which occurred in the pai region involving pentax endoscope model eg27-i10.In the event reported, the user stated that there was a potential endoscope contamination.The event timing is unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.
 
Manufacturer Narrative
Pentax medical issued rma (b)(4) for the device to be returned for further evaluation.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 insertion flexible tube (ift) crushed.Based on the result, we concluded that it was caused due to the excessive force applied on the ift.In addition, we confirmed that the distal body worn out, the bending rubber gluing discolored, and the suction channel kink.Correction information g6: follow up #1 h2: type of follow up.H6: coding changed based on the investigation result.Additional information h4: device manufacturer date.
 
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Brand Name
PENTAX
Type of Device
VIDEO GASTROSCOPE
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 Key13516988
MDR Text Key296314886
Report Number9610877-2022-00266
Device Sequence Number1
Product Code FDS
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEG27-I10
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Date Device Manufactured12/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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