MAUDE Adverse Event Report: SINCOHEREN LASER / BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD TABLETOP DIODE LASER; POWERED LASER SURGICAL INSTRUMENT

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

About 2 years ago, i purchased a laser for hair removal, from a (b)(6) company called sincoheren.I've had problems with it on/off since day one.There are no american companies that service their devices, so every time there's an issue, i have to contact them directly in (b)(6).The problem is that, every time i have an issue, (b)(6), my contact person at sincoheren, ignores my calls/texts for days at a time and when she does get back to me, she gives me the run around, etc., just nearly zero costumer service and no one else in the company available to help out.My most current issue started on (b)(6) 2019.I contacted (b)(6) because i was having a cooling issue with the handpiece of the laser.She stated that they no longer make this machine, which i just bought in 2018, but that she could have a new handpiece built for my laser for about (b)(6), or i could send in my handpiece to (b)(6), and they would fix it for (b)(6).I decided to send it in for repair.At some point she stopped responding to my text messages and i went on (b)(6) and started contacting other reps from the same company, who would respond right away, because they thought they were going to sell me something, but once they found out i was "(b)(6)customer", they couldn't help me.I contacted the company directly but no response.Ps - i sent the piece to (b)(6) for repair, than the coronavirus happened over there, and they were closed.But to make a long story short, i just got the handpiece delivered to me on (b)(6).It does not work, it still has the same cooling problem, it was obviously not repaired, yet they took my money.I contacted (b)(6) and of course, she is not getting back to me as usual.The reason why i want to file a complaint with the fda, is because this company (b)(6) is all over (b)(6), they have many pages by different reps fooling people, enticing american consumers to purchase their machines, claiming to be fda approved, always available and responding when one starts inquiring about one of their systems, and than when there is a problem, it takes forever for someone, or in my case (b)(6) to respond.I had to put many clients on hold for 3 months.It is very frustrating that one can not get the help one needs.In my opinion, this company should not be allowed to sell lasers in the usa without having us companies representing them, because lasers brake down and need to be repaired periodically, and sincoheren makes its nearly impossible to get any problem fixed.Plus, they sell their machines to anyone on the internet, and there are different classifications of lasers in the usa, and each state has their own regulations as to who can operate these devices, and not everyone can operate all the lasers that they sell, including myself.Please look into this matter, in order to prevent other americans from the same situation.This company is making money by fooling people.Feel free to contact me for further information, and i thank ou very much, for your prompt attention.Sincerely, (b)(6).(b)(4).

• Brand Name: TABLETOP DIODE LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SINCOHEREN LASER / BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
• MDR Report Key: 9915772
• MDR Text Key: 186433766
• Report Number: MW5094020
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/31/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1