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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX VIDEO CYSTOSCOPE 2.0C 5.5TP 400L

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX VIDEO CYSTOSCOPE 2.0C 5.5TP 400L Back to Search Results
Model Number ECY-1575K
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable. Model eb-1575k is available in the usa with a 510k number k131028. We checked the returned unit and confirmed that the ccd driver pcb malfunction. Based on the result, we concluded that it was caused due to the excessive force applied on the ccd driver pcb; however, other failure is not related to the alleged complaint. Based on the technical report, it was evaluated to submit mdr.
 
Event Description
The time of event is unknown. There was no report of patient harm. Video image failure.
 
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Brand NamePENTAX
Type of DeviceVIDEO CYSTOSCOPE 2.0C 5.5TP 400L
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 Key12687244
MDR Text Key278112795
Report Number9610877-2021-50135
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberECY-1575K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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