MAUDE Adverse Event Report: SYNERON MEDICAL LTD. VELASHAPE III; LASER SURGICAL INSTRUMENT FOR USE IN GENERAL AND PLASTIC SURGERY AND IN DERMATOL

Model Number FG71201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

The device was evaluated on site at the clinic.System passed testing; device found to be operating within candela specifications.A supplemental mdr will be submitted upon completion of the case investigation.

Event Description

According to the reporter, a (b)(6)-year-old female patient with fitzpatick skin type iii had a velashape vsmooth treatment to the abdominal area on (b)(6) 2020 that resulted in diffuse post treatment erythema.Post treatment localized erythema is not unusual related to this type of treatment and is not considered a serious or permanent injury.The patient called the clinic the next day stating she had a couple of "hard lumps" on her abdomen.The patient arrived at the clinic for a follow-up visit on (b)(6) 2020.According to the physician, the patient presented with soft tissue swelling and two hard lumps which were mobile and tender.One lump was approximately 1.5 cm (upper), and the other approximately 3 cm (lower).It was also noted there was no bruising and the rest of the abdomen was not tender.The patient was treated with non-steroidal anti-inflammatories (nsaids), and according to the treating physician was expected to heal.No serious or permanent injury identified at this time.Additional follow-up received 6 july 2020 indicated the patient "is recovering nicely.The lower mass is completely gone, while the upper one is much smaller.Patient asymptomatic." on 30 july 2020, candela received new information.The treating physician had received a text message from the patient notifying her that the patient had a ct scan which led to the diagnosis of "2 umbilical hernias," requiring surgical repair.Surgery was scheduled.On 7 august 2020 the treating physician reported to candela the patient had surgical repair on (b)(6) 2020 of a "small supra umbilical fat hernia." additional information was requested, but not yet received.Velashape treatment parameters according to the reporter at the time of treatment: if level: 2.Rf level: 3.Vacuum level: 2.Stacked pulses per pass 20 min total treatment time maintained temperature between 40 degree and 42 degrees celsius.

Manufacturer Narrative

Per surgical operative report, the patient's hernias were under 5mm in nature.Per the provider, the patient did not have any obvious defects or known history, however small, asymptomatic defects are difficult to detect.The patient had multiple previous treatment sessions which she underwent without incidence and she did not feel any pain or unusual symptoms during this particular treatment.The vacuum was not found to function any differently during this treatment.The device was examined by candela field service engineers and found to be within specifications.After review of the case, documentation and discussion with the physician, it cannot be concluded that the hernia was caused by the device.The lack of discomfort at the time of treatment, lack of symptoms in prior sessions, the inspection within specification of the device and the extensive history of safety of the velashape family of devices which includes a notable absence of similar complaints over the previous 15 years of use world-wide, leads to belief that the development of the patient's hernia and treatment are not causally related.Based upon analysis of case details as noted, the cause for this event could not be traced to device.Field h6 component code was left blank due to the fact that it was not determined if the device resulted in the adverse event and the component code 1023 was not available in esubmitter.

• Brand Name: VELASHAPE III
• Type of Device: LASER SURGICAL INSTRUMENT FOR USE IN GENERAL AND PLASTIC SURGERY AND IN DERMATOL
• Manufacturer (Section D): SYNERON MEDICAL LTD.; inductrial zone po box 550; yokneam, 20692 0; IS 206920
• MDR Report Key: 10457728
• MDR Text Key: 204531203
• Report Number: 3003772750-2020-00003
• Device Sequence Number: 1
• Product Code: NUV
• Combination Product (y/n): N
• PMA/PMN Number: K122579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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
• Device Operator: Other
• Device Model Number: FG71201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN
• Patient Outcome(s): Other
• Patient Age: 56 YR