MAUDE Adverse Event Report: HEALTHTRONICS, INC. ENDOCARE CRYOCARE CRYOPROBE 1.7MM; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number PCS-17

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Probe shaft frosted during simulated use testing.After test, probe disassembled for further evaluation.Vacuum sleeve was the cause of the shaft frosting.

Event Description

Two probes froze up the shaft.Probes pretested fine but once placed, frosted up the shaft.Doctor irrigated the shafts with saline to protect the skin.Complaint 1 of 2.

• Brand Name: ENDOCARE CRYOCARE CRYOPROBE 1.7MM
• Type of Device: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): HEALTHTRONICS, INC.; 9825 spectrum dr.; building 3; austin TX 78717
• Manufacturer (Section G): HEALTHTRONICS, INC.; 9825 spectrum dr.; building 3; austin TX 78717
• Manufacturer Contact: deborah wilcoxen ; 9825 spectrum dr.; building 3; austin, TX 78717 ; 5124398334
• MDR Report Key: 6853598
• MDR Text Key: 85782269
• Report Number: 3008262715-2017-00030
• 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: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Expiration Date: 09/12/2019
• Device Model Number: PCS-17
• Device Catalogue Number: PCS-17
• Device Lot Number: 20842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR