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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current user manual for the itero element 2 imaging system contains the following electric warnings: "do not connect the scanner to a mains supply without protective grounding, in order to avoid the risk of electrical shock".This event is being filed as an mdr as the user experienced a minor injury on hand, requiring visiting the emergency room, and the align technology, ltd.Medical device was being used.Investigation of this event is currently ongoing.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
Complainant reported that a user of an itero element 2 system experienced a minor burn on hand when plugging the cable into an outlet.The user required going to the emergency room to address the reported symptoms.No further information is available at this time.
Additional Manufacturer Narrative
No additional information about the user's condition was obtained despite attempts to gather this information, nor was the device returned for further investigation.The reported event was confirmed by review of available photographs and information supplied by the user.Align's clinical assessment of the available records indicate that the user's hand injury was a minor, superficial injury that did not pose any immediate risk to life, nor did it suggest the presence of significant trauma likely to result in permanent impairment or disability.With this, align concludes that the user sought hospital care as a precautionary measure.
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: 19495255
• Report Number: 3009646999-2024-01565
• Device Sequence Number: 21028979
• Product Code: NOF
• UDI-Device Identifier: 00816063020288
• UDI-Public: (01)00816063020288(11)220102
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: No
• Operator of Device: Other
• Device Model Number: 202965
• Device Catalogue Number: 202965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 08/25/2024; 11/01/2024
• Initial Report FDA Received Date: 06/09/2024
• Supplement Report FDA Received Date: 09/11/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown