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 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation complete.P/n# ttns3.00e4-1200.Lot#103117.S/n# (b)(4).The tip was used for 663 treatments.Tip passed flow, thermistor testing.Tip failed visual test due to dielectric breakdown being present.No leak test was performed.No functional test was performed due to dielectric breakdown being seen.

Event Description

The operator noted an odd smell and discovered a hole on the middle of the tip membrane with 537 pulses completed.There were no adverse event conditions noted by the operator.They replaced the tip and continued treatment.

Manufacturer Narrative

Corrected data: manufacture address, additional data: manufacture date.Additional mfr narrative - a review of the manufacturing records showed all requirements were met.Service confirmed damage to the treatment tip membrane.No patient injury occurred, but this damage could possibly cause patient burns.It is unknown what caused the hole in the treatment tip membrane.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Thermage technical user manual (p009240-04 rev.A) states inspect the treatment tips for any signs of physical damage prior to treatment.If any physical damage is found, do not use the damaged tip and replace it before initiating any treatment.The tip was and datacard were returned for evaluation.During evaluation of the treatment tip, product support found damage to the tip membrane.Solta medical has confirmed a low incidence (less than 1% of the total estimated number of treatments) of first- and second-degree patient burns associated with tears/cuts of the membrane of the treatment tip which contacts the patient during the thermage cpt procedure.Breakdown of the 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.Both the thermage user manual (p009240-04 rev.A) and technical bulletin tb-19 instructs 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.Thermage safety risk assessment (sha-09-001 rev.G) identifies damage to the treatment tip could potentially cause patient injuries such as burns.In addition to recommending frequent tip membrane inspection, solta emphasizes its recommendation to carefully monitor the condition of the patient¿s skin during treatment.In the case of a damage to membrane, the clinician may notice the onset of small burns which would be evidenced by small residual 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.A review of the manufacturing records showed all requirements were met.Service confirmed damage to the treatment tip membrane.No patient injury occurred, but this damage could possibly cause patient injuries such as burns.It is unknown what caused the hole in the treatment tip membrane.

• Brand Name: THERMAGE TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek parkway n ste100; bothell WA 98011
• MDR Report Key: 7311374
• MDR Text Key: 101492747
• Report Number: 3011423170-2018-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1