MAUDE Adverse Event Report: DENTSPLY LLC BOBCAT PRO 115V DOM PACKED(DNA); SCALER, ULTRASONIC

Catalog Number	81201
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While using a cavitron bobcat pro g130 they allege that they have no water flow or vibration and the handpiece is heating up, no injury resulted.
Additional Manufacturer Narrative
There has been a previous report received where lack of water flow has caused an overheating insert.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.
Additional Manufacturer Narrative
December 19, 2024 unit serial number-(b)(6) repair tech: gpb qa: mo root cause: 000/no fault found.Could not replicate the problem the customer has stated.Furthermore, the power and vibration of the unit itself is up to date to manufacturing standards.Foot pedal is up to date to manufacture specs.Water pressure is up to the manufactured specs and no leaks throughout the unit itself and no leaks throughout the water supply hose and the handpiece cable.Please always inspect all used inserts that are dentsply sirona inserts.Make sure that the inserts are not worn or damaged or clogged and or bent.Please check any loose connections when plugin the components into the unit itself.Note: replaced damaged/worn components and recalibrated unit to factory specs.The dhr review for this complaint is not required because the product was returned for evaluation and no fault was found.No further action is required.

• Brand Name: BOBCAT PRO 115V DOM PACKED(DNA)
• 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 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 20759805
• Report Number: 2424472-2024-00106
• Device Sequence Number: 15551889
• Product Code: ELC
• UDI-Device Identifier: D003812011
• UDI-Public: D003812011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 81201
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown