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

Model Number TT3.00E4-1200

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)

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

Event Date 10/28/2017

Event Type  malfunction  

Manufacturer Narrative

The treatment tip was returned for evaluation.During evaluation, the tip passed flow and thermistor testing.The treatment tip failed leak testing.Visual inspection found damage to the tip membrane (dielectric breakdown).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, the manufacturer recommends that a tip membrane inspection be performed at the outset of the procedure and every 50 (fifty) pulses thereafter.In addition, the manufacturer, emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during treatment.In the case of damage to membrane, the clinician may notice the onset of small burns, which would be evidenced by small focal red marks or white spots.Should this occur, it is up to the clinician¿s professional discretion to determine whether to continue treatment after replacement of the compromised tip.Solta also reiterates the importance of clinician attention to treatment error messages provided by the system, in particular messages indicating underforce and lifting irregularities.As with all thermage systems, ensuring perpendicular contact between the handpiece and skin is critical.

Event Description

Second degree minor burns were reported on the cheeks during treatment.The tip was inspected before and during the treatment.A pin hole was discovered in the tip.The evaluation of the returned tip found that the tip membrane had dielectric breakdown.The blisters are resolving and are expected to heal without permanent scarring.

• Brand Name: THERMAGE TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL; 11720 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7527800
• MDR Text Key: 108901800
• Report Number: 3011423170-2018-00041
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2017
• Device Model Number: TT3.00E4-1200
• Device Lot Number: 012516-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR