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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO CYSTOSCOPE Back to Search Results
Model Number ECY-150S
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2023
Event Type  malfunction  
Event Description
The time of event is unknown.There was no report of patient harm.Bending rubber adhesive falls off.
 
Manufacturer Narrative
This device is not distributed in us so that 510k# is blank.We checked the returned unit and confirmed that the bending rubber gluing as missing.Based on the result, we concluded that it was caused due to the excessive force applied on the bending rubber.In addition, we confirmed that the u/d lock knob lever broken, the ift buckled, the lg cable buckled, the suction arm deformed, the control body worn out, the biopsy inlet t-piece worn out, the lg cable connector worn out, the lg cable connector housing worn out and the u/d lock lever white marking faded; however, they are not the main cause, and/or irrelevant to the alleged complaint.Confirming pm in japan, in this case it could not be denied that the glue falls occurred in the human body.Therefore, based on the technical report ""hr-rpt-0581(bending rubber)"" and/or the risk analysis results, it was evaluated to submit mdr.
 
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Brand Name
PENTAX
Type of Device
VIDEO CYSTOSCOPE
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
MDR Report Key16483784
MDR Text Key310679594
Report Number9610877-2023-52009
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeJA
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 03/06/2023
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 NumberECY-150S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2023
Initial Date FDA Received03/06/2023
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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