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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-1575K
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Pma/510k: pentax medical model dp-d2518 is not distributed in the usa, therefore the pma/510(k) number is not applicable. (b)(4).

 
Event Description

Pentax medical was made aware of a complaint on (b)(6) 2019 that occurred in (b)(6). The reported complaint of "bending rubber section of the scope was damaged when removed from patient" involving the pentax medical video cystoscope during a procedure. No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported. Pentax medical (b)(4) sales rep provided an image of the failure and model: ecy-1575k, serial number (b)(4) on 29mar2019. Currently awaiting requested additional information.

 
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Brand NamePENTAX
Type of DeviceVIDEO 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 (temporary)
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key8482843
MDR Text Key142651035
Report Number9610877-2019-00272
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberREFER TO H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/03/2019,03/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberECY-1575K
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/03/2019
Distributor Facility Aware Date03/07/2019
Event Location Hospital
Date Report TO Manufacturer04/03/2019
Date Manufacturer Received03/07/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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