MAUDE Adverse Event Report: ENDOCARE INC. ENDOCARE CRYOCARE CRYOTHERAPY SYSTEM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number CRYO-CS

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

Patient under anesthesia when determination was made to cancel the case.

Event Description

During pretest the probes successfully created ice balls but when the thaw process was started an error message was seen indicating that the thaw had failed.Checked all connections, shut system down and tried again and still the same error message.Case canceled.

Manufacturer Narrative

Endocare field service engineer evaluated device by simulated use testing.Performed several operational tests but unable to duplicate reported issue.

• Brand Name: ENDOCARE CRYOCARE CRYOTHERAPY 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 Key: 8346022
• MDR Text Key: 136730844
• Report Number: 3008262715-2019-00018
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153489
• Number of Events Reported: 1
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRYO-CS
• Device Lot Number: 05-0014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR