MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA SURGICAL #3 PACK; SCALER, ULTRASONIC

Catalog Number	PUSURG3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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 proultra surgical #3 pack - 2 proultra surgical #3 tips broke during use on the same patient.No injury.
Additional Manufacturer Narrative
Additional information received: dr had 2 tips break on the first use on the same patient.Dr was using a low setting" no more details.Reviewed proper use and speed setting.Replacing.No patient injury unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented (see notes).Case can be re-opened if product is received.Nothing unusual to report was found during dhr review.A query indicates one additional complaint has been received for this lot number.(b)(4) (from same account).

• Brand Name: PROULTRA SURGICAL #3 PACK
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22024945
• Report Number: 2320721-2025-00070
• Device Sequence Number: 15258909
• Product Code: ELC
• UDI-Device Identifier: D716PUSURG31
• UDI-Public: D716PUSURG31
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: PUSURG3
• Device Lot Number: 376723
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown