MAUDE Adverse Event Report: DENTSPLY LLC BOBCAT PRO 115V EXP PACKED; SCALER, ULTRASONIC

Catalog Number	81202
Medical Device Problem Code	Restricted Flow rate (1248)
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 a bobcat pro 115v exp packed allegedly has water issues, it does not increase the water level as soon as it is set to the maximum level and overheats.No injury.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the evaluation.As of this review, the device in question has not been received.The device history record (dhr) was examined, and no issues or deviations were found that could have led to the reported event.Should additional relevant information become available, a supplemental report will be submitted.Dentsplysirona will continue to monitor field performance for this device.

• Brand Name: BOBCAT PRO 115V EXP PACKED
• 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: 21959987
• Report Number: 2424472-2025-00220
• Device Sequence Number: 15752416
• Product Code: ELC
• UDI-Device Identifier: D003812011
• UDI-Public: D003812011
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033705
• 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): 09/03/2025

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
• Device Catalogue Number: 81202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown