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

Model Number PCS-17

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Device history records reviewed.Device not returned for evaluation.Shaft frosting is a known risk for cryoprobes.

Event Description

Upon freezing during this procedure, it was observed that both pcs-17 cryo probes frosted all the way up shaft.There was no delay to the procedure and no injury to the patient, the case and treatment was completed as scheduled.Complaint 1 of 2.

• Brand Name: ENDOCARE CRYOCARE CRYOPROBE
• 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: 6918821
• MDR Text Key: 89851141
• Report Number: 3008262715-2017-00039
• 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: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR