MAUDE Adverse Event Report: DENTSPLY LLC SMARTLITE PRO INTRO KIT; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Catalog Number	644400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that smartlite pro intro kit slp on the led tip get extremely hot and that it has caused postoperative discomfort, pulpitic discomfort and thus endo-treatments as a result after inserting inlays.The customer reportedly, heat generated would cause massive postoperative, pulpitic complaints after insertion of the inlays and he would have several endo treatments as a result.
Additional Manufacturer Narrative
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation results: we receive yesterday 06th september the complaint smartlite pro here at the equipment service in radolfzell.I have check light power of the cure tip and it is with 976 mw/cm² inside the specification.Also the illuminate tip is with 12 mw/cm² (low) and 24 mw/cm² (high) inside the specification.The temperature at the cure tip backside is after 4x10 sec.On / 5 sec.Off with 28,5°c inside the specification.The battery capacity of both batteries are with 563 mah and 577 mah inside the specification.So don't can find a technical problem on this smartlite pro.Our repair no.199185, 199186 and 199187.

• Brand Name: SMARTLITE PRO INTRO KIT
• Common Device Name: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17651458
• Report Number: 2515379-2023-00094
• Device Sequence Number: 12345127
• Product Code: EBZ
• UDI-Device Identifier: D0026444001
• UDI-Public: D0026444001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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
• Device Catalogue Number: 644400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown