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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2023
Event Type  malfunction  
Event Description
The time of event is not during procedure.There was no report of patient harm.Video image failure(objective lens broken).
 
Manufacturer Narrative
The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the objective lens broken.Based on the result, we concluded that it was caused due to the excessive force applied on the objective lens.In addition, our technician confirmed that the suction channel buckled, the air nozzle missing, the water nozzle missing, the bending rubber leak, the remote control buttons leak, the junction case loose, the insertion flexible tube worn out, the distal body worn out, and the segment worn out; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
 
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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
akishisima-shi, tokyo 196-0 012
JA  196-0012
Manufacturer (Section G)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishisima-shi, tokyo 196-0 012
JA   196-0012
Manufacturer Contact
william goeller
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key18390674
MDR Text Key331300143
Report Number9610877-2023-62457
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K131902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/26/2023
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2023
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received12/26/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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