MAUDE Adverse Event Report: HEALTHTRONICS, INC. VARIAN¿ 1.7 MM LONG SHAFT RENALCRYO¿ CRYOPROBE; RS-17L

Model Number	RS-17L
Health Effect - Clinical Codes	Burn, Thermal (2530); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)
Date of Event	03/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return of probe and additional information has been requested.
Event or Problem Description
During the procedure the perc-17 probe gave the patient a dime sized thermal injury to the skin.
Additional Manufacturer Narrative
Original report received identified the device as a perc-17 but gave no lot number.User facility report, received via fda, provided device lot number.Device history record review revealed probe is an rs-17l, not a perc-17 as originally reported.Device not returned for evaluation.
Event or Problem Description
Probe created a dime size thermal injury on right lower back.
Additional Manufacturer Narrative
Device received 06/24/2016.Simulated use testing confirmed the reported issue.Evaluation found the vacuum sleeve failed and was the cause of the frosting.
Additional Manufacturer Narrative
This report is to provide corrected information to a previously submitted medwatch with report number 3008262715-2016-00010 with a report date 03/17/2016.This report is being submitted as requested by fda to add the related report number 2400100000-2016-8007 to corresponding block h10.
Event or Problem Description
See completed medwatch: mfr report #: 3008262715-2016-00010.

• Brand Name: VARIAN¿ 1.7 MM LONG SHAFT RENALCRYO¿ CRYOPROBE
• Common Device Name: RS-17L
• Manufacturer (Section D): HEALTHTRONICS, INC.; 9825 spectrum drive; building 3; austin TX 78717
• Manufacturer (Section G): HEALTHTRONICS, INC.; 9825 spectrum drive; building 3; austin TX 78717
• Manufacturer Contact: nia van baalen ; 911 hansen way; building 3; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 5547522
• Report Number: 3008262715-2016-00010
• Device Sequence Number: 562147
• Product Code: GEH
• UDI-Device Identifier: 00810563020052
• UDI-Public: (01)00810563020052(11)150721(17)180721(10)18149
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 07/21/2018
• Device Model Number: RS-17L
• Device Lot Number: 18149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2016
• Supplement Date Received by Manufacturer: Not provided; 03/17/2016
• Initial Report FDA Received Date: 04/05/2016
• Supplement Report FDA Received Date: 06/02/2016; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown