MAUDE Adverse Event Report: SOLTA MEDICAL THERMAGE TIP; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TTNS3.00E4-1200

Device Problem Hole In Material (1293)

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

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

The treatment tip was returned for evaluation.During evaluation, the tip passed flow and thermistor testing.Visual inspection found damage to the tip membrane (dielectric breakdown).Evaluation of the datacard found multiple system errors had occurred during treatment.The device history record was reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Breakdown of the treatment tip membrane can cause the radiofrequency energy, delivered by the system, to focus in a small area of the membrane, rather than to be uniformly distributed over the entire membrane area.The thermage user manual and the technical bulletin instruct the operator to inspect the treatment tips for any signs of physical damage prior, during and after treatment.With respect to all thermage systems, clinicians should frequently inspect the tip membrane during treatment for signs of breakdown and build-up of foreign substances.With respect to the cpt system, solta recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.Solta also reiterates the importance of clinician attention to treatment error messages provided by the system, in particular messages indicating underforce and lifting irregularities.

Event Description

It was reported that during a treatment session to the face and neck, the patient experienced discomfort, redness and some white welts on the left side of the neck.Reportedly, the patient did not require any treatment and was fine during follow-up visit with all symptoms resolved.Reportedly, the tip was inspected after the patient complaint of discomfort and a pinhole size, black mark at the middle of the tip membrane was noticed.Evaluation of the returned treatment tip identified the damage on the tip surface as dielectric breakdown.

• Brand Name: THERMAGE TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL; 11720 n creek parkway n ste 100; bothell WA 98011
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7470895
• MDR Text Key: 107323721
• Report Number: 3011423170-2018-00032
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Device Lot Number: 052617-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other