MAUDE Adverse Event Report: SUNIMEDICAL IMAGING, INC. SUNI; SUNIRAY DENTAL DIGITIAL X-RAY SENSOR

Model Number SENSOR SIZE #1

Device Problems Break (1069); Detachment Of Device Component (1104); Connection Problem (2900); Torn Material (3024)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  malfunction  

Event Description

Defective connectors/usb receptacles in radiograph sensors.This resulted in inconsistent and un-reliable connection of sensors to our computers, and this resulted in the need to retake radiographs, thus increasing patient exposure to radiation.Plastic housing for the sensor plates opened at the seams on two of my sensors, resulting in unrepairable damage to one sensor and unknown number of necessary retakes.Failure of our sensor, replaced by manufacturer (under warranty).When a representative from suni, mr.(b)(4) installed software and trained me and my staff to use the sensors, he told us that the usb connectors were easily dislodged and that care should be taken while moving cords, etc.One of these sensors failed during the warranty period and was replaced by the company.We experienced problems every day with usb connections being lost during normal use because the connectors would jiggle in the receptacles.This resulted in numerous re-exposures to obtain images.In addition, i had to purchase new usb cables because the connectors became worn/defective from the movement in the connectors.The usb receptacle in one sensor became detached from the circuit board of the sensor interface.Since the sensor was not abused or dropped, this appears to be due to repetitive stress from unsecured connections.I sent this sensor to suni to be evaluated for a solution.The company replied with the following responses: the sensor was out of warranty, so they would not replace it.They said that the plastic housing around the sensor plate had opened at the seams, resulting in unrepairable damage to the sensor.They said that the sensor must have been abused.My response to this was to inform them of the following: i had problems daily with unsecured usb connections which had to place stress on the connections and could cause the receptacle to break off this board.I pointed out that in two conversations i had with one of their employees (mr.(b)(4)) i was told that my complaint about this was legitimate and that this was a common problem with their sensors and is why they changed the design.I told mr.(b)(4) and mr.(b)(4) (their representative in charge of handling problems with products) that it's clear that i and other dentists effectively were their beta testers and that since they knew of these problems, they should replace my sensor.I told mr.(b)(4) that the sensor housing was intact when i was in possession of it and that it was shipped with a lot of padding and it was double-boxed for added protection.So, the housing separated after it left my office.In addition, i told mr.(b)(4) that in the meantime, another of my sensors had the plastic housing separate at the seams.This sensor is the one that the company sent me to replace my original sensor that had failed.Evidently there is a defect in the way they assemble the sensor housing.I have not received a reply regarding this problem.My sensors have never been dropped or abused by me or my staff.We have followed all instructions and precautions provided by the manufacturer, both in written form and as verbally expressed during our in-office training by mr.(b)(4).We have always used sensor holders recommend by suni.I finally had a phone conversation with mr.(b)(4), who insisted that the company had no responsibility since the sensor was out of warrantees.I went through all my points again and said that in light of what i had been told and the fact that the company was aware of such defects, i felt that they do indeed have a responsibility to me and that the safety of my patients is of utmost importance.I insisted that the company replace my sensor and that they give me an answer about what they will do about my other sensor with a separated housing.Mr.(b)(4) said he would discuss this with his superiors.In the meantime, a representative of the dental software company that originally recommended suni products contacted suni, in support of my expectations of suni.I then received a reply from mr.(b)(4) offering to sell me a new sensor at a discount.I replied that this is not acceptable at any price, since the issue is a defect that affected me and numerous other offices and the company knew it.Mr.(b)(4) eventually emailed me that i would receive a replacement sensor, but with no warranty.Upon receiving the replacement sensor, it was immediately obvious that it was not a new one, since it was not in original packaging.When i tried to test it, i could not insert the usb cable plug completely into the sensor receptacle and i couldn't get connectivity with my computers unless i hand-held the usb cable together with the sensor.I discovered that this sensor was obviously a used one that also had the usb receptacle break away from the board.Suni evidently tried to repair it and reinforce with what appears to be glue from a hot glue gun.I did not attempt to use this on a patient and i informed (through email) the executives of suni and mr.(b)(4) of this and that i expected proper resolution.To date, they have not responded.I have done everything i can to reasonably work with suni to resolve this issue while protecting my patients from further unnecessary exposure to radiation as a result of their defective products.Hopefully you can help me and other doctors to resolve this issue in our efforts to provide safe treatment for our patients.

• Brand Name: SUNI
• Type of Device: SUNIRAY DENTAL DIGITIAL X-RAY SENSOR
• Manufacturer (Section D): SUNIMEDICAL IMAGING, INC.; 6840 via delord; suite 160; san jose CA 95119
• MDR Report Key: 4059743
• MDR Text Key: 4735316
• Report Number: MW5038041
• Device Sequence Number: 2
• Product Code: MUH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/05/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SENSOR SIZE #1
• Device Catalogue Number: P/N: 400-1226-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1