MAUDE Adverse Event Report: ALIGN TECHNOLOGY, LTD. ITERO ELEMENT 2; SYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM)

Model Number	202965
Medical Device Problem Codes	Overheating of Device (1437); Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The current user manual contains the following warnings: "do not connect the scanner to a mains supply without protective grounding, in order to avoid the risk of electrical shock", "do not use the equipment if a scanner malfunction occurs or if physical damage is observed, in order to avoid electrical shock or physical injury.Call customer support", and "avoid twisting, knotting, pulling, and stepping on the wand cable and the power cable".An investigation into the root cause of the event is being conducted.Back in jan-2023, an investigation was performed on the power cable damage issue (with no injury) and concluded that power cable damage can get damaged due to the incautious use.In addition, a previous event led to the investigation of an additional defective cable and a corrective action is already in place to investigate and correct this issue.This event is being reported as an mdr due to minor injury (burn) due to malfunction of medical device.
Event or Problem Description
The treating doctor reported the event: while trying to plug in the power cable the user sensed a minor electrical discharge and a spark from the cable which caused a minor skin burn.It happened as she applied higher force than usual to plug it in.She went to get checked out in the hospital but was not hospitalized.It is unknown if any medications were prescribed to alleviate the reported minor injury (burn).The staff member is doing fine.There was no smoke present.There were no power outages reported.It is unknown if a circuit breaker was present.Image attached for minor injury (burn).
Additional Manufacturer Narrative
A thorough investigation was performed to assess this event.A cross functional team analyzed the investigational findings and determined the severity of the reported deficiency, evaluated the hazard, and considered the potential risk to patients and users.It was concluded that no further actions are required to prevent the re-occurrence of the harm.The company did decide to increase the robustness of the cables to meet the observed use conditions, as a result of this investigation.No clear trend is identified, but we continue monitoring to make sure there is no change to the trend or any change that could affect this decision.Additiional data: h6 investigation findings updated with code 122 after investigation completed.H6 investigation conclusions updated with code 4319 after investigation completed.
Event or Problem Description
The treating doctor reported the event: while trying to plug in the power cable the user sensed a minor electrical discharge and a spark from the cable which caused a minor skin burn.It happened as she applied higher force than usual to plug it in.She went to get checked out in the hospital but was not hospitalized.It is unknown if any medications were prescribed to alleviate the reported minor injury (burn).The staff member is doing fine.There was no smoke present.There were no power outages reported.It is unknown if a circuit breaker was present.
Additional Manufacturer Narrative
Updates were made after reviewing the quality of device identification information submitted previously against data in the gudid.

• Brand Name: ITERO ELEMENT 2
• Common Device Name: SYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM)
• Manufacturer (Section D): ALIGN TECHNOLOGY, LTD.; 1 yitzhak rabin rd.; petach-tikva, central 49251 10; IS 4925110
• Manufacturer (Section G): ALIGN TECHNOLOGY, LTD.; 1 yitzhak rabin rd.; petach-tikva,, central 49251 10; IS 4925110
• Manufacturer Contact: harper shore ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 17760756
• Report Number: 3009646999-2023-02628
• Device Sequence Number: 20635554
• Product Code: NOF
• UDI-Device Identifier: 00816063020288
• UDI-Public: (01)00816063020288(11)201018
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

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
• Device Model Number: 202965
• Device Catalogue Number: 202965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 11/01/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/24/2023; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female