MAUDE Adverse Event Report: ALIGN TECHNOLOGY, LTD. ITERO ELEMENT 5D PLUS CART CONFIGURATION; CARIES DETECTOR, LASER LIGHT, TRANSMISSION

Model Number	211484
Medical Device Problem Codes	Overheating of Device (1437); Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When removing the plug from the socket, flames formed at the transition between the plug and the cable and sparks/smoke were emitted from the socket.The office reported that a person in the office was injured (no patient was reported to be injured).Upon assessment of the event, the burn appears to be related to heat and not due to electrical shock.The scanner operator hands were dry.There was a minor injury (superficial burn) in the finger that did not require any medical intervention.
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".In a rare case (1 event out of 85,000 active scanners) a report was made that a damaged power cable caused a minor injury to a user.No medical intervention was needed.Up to that case no user reported any harm due to the issue.An investigation in to 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.Initial reporting is being submitted until align completes the investigation.
Event or Problem Description
When removing the plug from the socket, flames formed at the transition between the plug and the cable and sparks/smoke were emitted from the socket.The office reported that a person in the office was injured (no patient was reported to be injured).Upon assessment of the event, the burn appears to be related to heat and not due to electrical shock.The scanner operator hands were dry.There was a minor injury (superficial burn) in the finger that did not require any medical intervention.
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.
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 5D PLUS CART CONFIGURATION
• Common Device Name: CARIES DETECTOR, LASER LIGHT, TRANSMISSION
• 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: 17491663
• Report Number: 3009646999-2023-02160
• Device Sequence Number: 17955275
• Product Code: NTK
• UDI-Device Identifier: 00816063020691
• UDI-Public: (01)00816063020691(11)210506
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• 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: Health Professional
• Device Model Number: 211484
• Device Catalogue Number: 211484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2023
• Supplement Date Received by Manufacturer: 07/04/2023; 11/01/2024
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/24/2023; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: Unknown