MAUDE Adverse Event Report: DENTSPLY LLC 66 SURF W/STERI-MATE 360; SCALER, ULTRASONIC

Catalog Number	8800003
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability 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.
Event or Problem Description
In this event it is reported that 66 surf w/steri-mate 360 got hot during use.No injury occurred.
Additional Manufacturer Narrative
On 07/10/2024 (b)(4).Root cause code: eyv pwr supply/transformer open.Accessories received for evaluation, open power supply/transformer, damaged scaler adaptor harness due to bad crimping.The unit works fine when hooked up to a good transformer and scaler adaptor.Dhr review is not required because the product was returned for evaluation.The service technician was unable to duplicate the failure listed in the complaint with the returned unit.No further action required.

• Brand Name: 66 SURF W/STERI-MATE 360
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19475724
• Report Number: 2424472-2024-00373
• Device Sequence Number: 14461947
• Product Code: ELC
• UDI-Device Identifier: D00388000031
• UDI-Public: D00388000031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052334
• 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): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8800003
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown