MAUDE Adverse Event Report: CUTERA, INC. EXCEL HR; POWERED LASER SURGICAL INSTRUMENT

Medical Device Problem Codes	Output above Specifications (1432); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Erythema (1840); Swelling/ Edema (4577)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated with a 755 nm laser for hair reduction.The treated area developed patches of brusing where the laser energy was delivered.The brusing was managed using topical creams containing 2% hydrocortisone mixed with biafine and is expected to resolve.The laser system was evaluated by field service, and the 755 nm laser output energy was determined to be 17% to 34.6% higher than expected.The laser system was recalibrated and subsequently met performance specifications.
Event or Problem Description
The patient was treated with a 755 nm laser for hair reduction.The treated area developed significant perifollicular erythema and edema, which was originally mischaracterized as bruising.Perifollicular erythema and edema are both well-known and documented expected transient side effects of laser hair removal treatments.The erythema and edema were managed using topical creams containing 2% hydrocortisone mixed with biafine and have resolved.The initial mdr was filed because it was believed that the laser may have malfunctioned and emitted significantly higher pulse energy than expected; however, the investigation has determined that the energy meter or energy detector head used by the fse who visited the site was measuring significantly different values for similar energies when delivered into different sized treatment spots, with the variance from nominal being monotonically higher for larger spots.The absence of any errors being recorded in the device's error log confirms that the device was functioning fully as intended during the treatment in question.Since the laser was functioning as intended, the initial serious incident report filed is hereby withdrawn.

• Brand Name: EXCEL HR
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005 ; 4156575575
• MDR Report Key: 19582388
• Report Number: 2954354-2024-00008
• Device Sequence Number: 7279830
• Product Code: GEX
• UDI-Device Identifier: 00816722021502
• UDI-Public: 010081672202150211231117
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K153671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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?: Yes
• Operator of Device: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White