PICOSURE

Report

Report Number: 1222993-2024-00017
Event Type: Injury
Date Received: April 19, 2024
Report Date: April 19, 2024
Manufacturer: CYNOSURE LLC
Product Code: GEX
PMA / PMN Number: K210226
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CYNOSURE'S CLINICAL TEAM INVESTIGATED THE EVENT AND CONFIRMED USER ERROR WAS INVOLVED. PHOTOS OF THE PATIENT WAS PROVIDED AND CLINICAL DETERMINED PATIENT WAS INCORRECTLY ASSESSED. PATIENT'S FITZPATRICK APPEARS TO BE FITZ IV BUT WAS ASSESSED AS FITZ VI. SITE DID NOT PERFORM A TEST SPOT PRIOR TO TREATMENT ALTHOUGH RECOMMENDED PER LABELING. LABELING ALSO INSTRUCTS: LARGER SPOT SIZES WITH LOWER FLUENCE SHOULD BE USED IN HIGHLY PIGMENTED TATTOOS, AS WELL AS WITH TATTOOS ON EXTREMITIES. SITE PERFORMED TREATMENT WITH 4MM TIP ON THE EXTREMITY OF PATIENT'S WRIST AND INK WAS DENSE AND BLACK. CYNOSURE MEDICAL DIRECTOR ALSO REVIEWED THE INCIDENT AND SUSPECTS SPOT SIZE WAS TOO SMALL GIVEN THE DENSE BLACK INK AND THE FITZPATRICK OF THE PATIENT. PER CYNOSURE MEDICAL DIRECTOR: PATIENT'S WRIST HAS PARTIAL THICKNESS BURN AND FLANK FULL THICKNESS BURNS. SOME LEVEL OF SCARRING IS EXPECTED. PATIENT IS ADVISED TO FOLLOW UP WITH SOMEONE SKILLED WITH BURN TREATMENT. PATIENT WAS GIVEN TOPICAL SILVADENE AS PREVENTATIVE MEDICATION. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. COMPLIMENTARY VIRTUAL TRAINING WAS DISPATCHED TO THE SITE. BURNS ARE EXPECTED SIDE EFFECTS FROM LASER TREATMENTS, HOWEVER PERMANENT SCARRING IS A LIKELY OUTCOME AND THEREFORE REPORTABLE.

Description of Event or Problem · 0

IT WAS REPORTED THAT PATIENT EXPERIENCED A BURN FOLLOWING A TATTOO REMOVAL TREATMENT USING PICOSURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1111020	PICOSURE	PICOSURE	GEX	CYNOSURE LLC

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Other