MAUDE Adverse Event Report: RAY CO., LTD RAYSCAN LED; X-RAY, TOMOGRAPHY, COMPUTED, DENTAL

Device Problems Power Conditioning Problem (1474); Use of Device Problem (1670); Noise, Audible (3273)

Patient Problems Burning Sensation (2146); Physical Entrapment (2327); Radiation Exposure, Unintended (3164)

Event Date 07/09/2018

Event Type  Injury  

Event Description

I went to an orthodontist office to see about getting braces.So an older lady calls me back and looks in a hurry because the place is extremely busy for such a small cheap building in (b)(6).So they don¿t even talk to me to see what problems i have.They just quickly tell me in the load hall and operation room that they want to take a quick scan on me.So nervously i say ok.I thought it would be some kind of photograph of my teeth.I didn¿t really know what it meant.Later i find out it was full blown computed x-ray machine that takes many x-rays and has radiation.They never told me that beforehand.But this is all a side problem.On the second machine it drastically malfunctioned.It was a rayscan cephalometric device that she said he was having trouble setting it up for my height and size.Then i tried to tell her to stop but she was hell bent on doing it.Then she started mashing the adult setting on the remote and start button several times and said ¿she couldn¿t get it to.¿ didn¿t finish her sentence.I was really worried now and tried to talk to say i didn¿t want to do it anymore but my mouth was tied in and clamped.Then the machine started.From my back right side it started to rotate forward and got caught on the back of my right shoulder for about 2-3 seconds then it started to buzz really loud and shake some so i realized it was caught on my shoulder because she didn¿t want to set it up correctly.So i had to dip my shoulder down a few inches on the side and then the machine got free and started buzzing even louder and moving faster and the lights barely flickered in the room and there was a surge or heat and energy to the machine, and well i don¿t like to admit what happened especially in writing.It threw a pain into my brain i don¿t like to talk about or write about.I tried to pull out of the apparatus but i was tied in and it was painful and felt like touching a black hot car on a summer day left in the sun but in my brain and much worse.The rayscan device did somewhat calm down after about 4 seconds but it was still not working right.Then it ended.I pulled everything off and rushed out of the room.The old lady tried to play it off like it was my fault.I didn¿t know what to think.I was in a daze and didn¿t understand why that would happen and how serious it was.(it ended up being very serious, ¿radiation poisoning¿, exposure around 5-15 greys).I didn¿t cause a scene and she didn¿t want to report it.I did finally see the orthodontist in another room and tried to talk about what problems i had with my teeth as that is all he wanted to talk about and was in a major hurry.Ultimately, i just left about 10 minutes later and didn¿t confront them, although i should¿ve.I didn¿t know what to do at the time.I even think a generator kicked on, on top of the one story flat roof building cause i saw a change in the lights in the room and heard a generator kick on or transformer on top of the building or right on the back of the small building.It was a small building and they were using every device in the building in a hurry being a monday after the (b)(6).I¿d never seen so many people (teens) being worked on at once and so much noise of devices being used in the next room.They had about 15 people waiting and 10 people being worked on.For a small 900 square foot building.Probably a fire safety code violation as well.Anyways there was some kind of major problem with that rayscan machine and disturbance.No doctor wanted to try to treat me for radiation overexposure because it's something doctors don't know much about.I've learned a lot about it now.It can malfunction and there should be risk warnings at dentists and orthodontists.Also they should probably never do them.I've learned that people have died and i'm struggling.

• Brand Name: RAYSCAN LED
• Type of Device: X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
• Manufacturer (Section D): RAY CO., LTD
• MDR Report Key: 8372026
• MDR Text Key: 137368508
• Report Number: MW5084405
• Device Sequence Number: 1
• Product Code: OAS
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 37 YR
• Patient Weight: 100