MAUDE Adverse Event Report: CUTERA, INC. EXCEL HR

Model Number EXCEL HR

Device Problems Crack (1135); Failure to Deliver Energy (1211); Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

On october 20, 2023, cutera's distrubutor reported an incident where that the umbilicial cord (fiber tube) associated with the handpiece exploded/sparked during an excel hr treatment.It appears that laser energy escaped from the umbilical cord.No injuries resulted from this energy release.Cutera is currently in the process of following up with the site to gather additional information about this incident and to retreive the affected handpiece for a comprehensive investigation.

Manufacturer Narrative

Cutera is in the process of following up with the clinic to obtain more information about the affected device.Based on the video and photo images obtained, its appears that the optic fiber has been damaged at the handpiece junction.Futher investigation is pending until the affected handpiece is returned from the clinic.

Manufacturer Narrative

A replacement handpiece and permanently attached umbilical cable was provided to the customer.The damaged umbilical cable (and attached handpiece) was recovered by the distributor and returned to cutera for investigation into factors that contributed to the incident and to determine if additional corrective actions were required.The full investigation report is attached, and its primary findings are summarized below: 1.The damage to the umbilical cable was caused by a break in the optical fiber enclosed therein with the break located just prior to the handpiece.Energy delivered into the optical fiber of the handpiece, including the visible red aiming beam, exited the fiber at the break and there heated the inner steel monocoil and overlying rubber insulation of the protective umbilical cable to the point where the steel of the monocoil and rubber insulation both melted creating holes almost perpendicular to the cable and fiber through which the sparks (tiny super-heated metal fragments) reported and seen in the video were ejected.2.The umbilical cord (steel monocoil enclosed in rubber insulation) acted as intended to prevent potential harmful laser energy escaping from the umbilical cord in the event of an optical fiber break.3.The primary cause of the incident was that the operator, after she knew 1) there was no aiming beam, 2) there was no treatment beam (lack of effect), and 3) there was a kink in the umbilical cable adjacent to the handpiece, continued to fire the laser, contrary to the ifu, until enough energy had be absorbed by the steel monocoil to melt a small hole in it and the overlying rubber insulation allowing the sparks to be released.4.Exactly how or when the optical fiber broke, and/or if it was caused by the steel monocoil being bent too tightly forming a kink, could not be determined other than that it must have occurred prior to the video beginning and at some time during or after the devices was last used.No further corrective action is required.

Event Description

On october 20, 2023, cutera's distributor for poland reported an incident they'd learned of earlier that day.The incident occurred on 10/17/2023 at a customer site during an excel hr hair removal treatment.Cutera's distributor, after speaking with the customer and seeing a video sent to them by the customer that showed the incident, reported "the umbilical cord (fiber tube) exploded/sparked next to the handpiece".The video was forwarded to cutera with the initial report.It shows 3 treatment attempts on the same patient with the first two being aborted 6 to 10 pulses into the treatments due to no treatment effect, no patient reaction, and possibly the absence of the red aiming beam that should be visible.In the final treatment attempt, a spray of sparks can be seen being ejected from the umbilical cable during a pulse immediately prior to the treatment being aborted.The video shows nothing to support the use of the term "exploded"; its use in the distributor's initial report is speculative and premature.No injuries to the patient or operator occurred during the incident.

• Brand Name: EXCEL HR
• Type of Device: EXCEL HR
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore boulevard; brisbane CA 94005
• Manufacturer (Section G): CUTERA, INC.; 3240 bayshore boulevard; brisbane CA 94005
• Manufacturer Contact: philipp novales-li ; 3240 bayshore boulevard; brisbane, CA 94005 ; 4156575590
• MDR Report Key: 18166372
• MDR Text Key: 328655967
• Report Number: 2954354-2023-00001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K132185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXCEL HR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention