Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOCARE INC. ENDOCARE URETHRAL WARMING SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ENDOCARE INC. ENDOCARE URETHRAL WARMING SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES Back to Search Results
Model Number CRYO-63
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2019
Event Type  malfunction  
Event Description
Warmer error code 50.System would not warm fluid.
 
Manufacturer Narrative
Product was not returned for evaluation.Field service engineer could not duplicate the fault.Per the manufacturers warmer fault code table within the system manual, the error code 50 is indicative of a heater over-temperature protection fault.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDOCARE URETHRAL WARMING SYSTEM
Type of Device
UNIT, CRYOSURGICAL, ACCESSORIES
Manufacturer (Section D)
ENDOCARE INC.
9825 spectrum dr.
building 2
austin TX 78717
Manufacturer (Section G)
ENDOCARE INC.
9825 spectrum dr.
building 2
austin TX 78717
Manufacturer Contact
deborah wilcoxen
9825 spectrum dr.
building 2
austin, TX 78717
5125181743
MDR Report Key8625147
MDR Text Key145758689
Report Number3008262715-2019-00076
Device Sequence Number1
Product Code GEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153489
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCRYO-63
Device Catalogue NumberCRYO-63
Device Lot NumberR16271-5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age73 YR
-
-