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

Catalog Number	PUENDO3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received 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.Investigation results: dhr: nothing unusual to report was found during dhr review.A query indicates no additional complaints have been received for this lot number.Return: customer returned 1x puendo3 lot 0000453817 broken.Using microscope visually checked tip.Instrument was broken as indicated in complaint, see attached picture.No manufacturing defects or markings were noted on instrument.It is recommended that the tip be at treatment site before engaging power.Also, these tips should be used with water.No unopened product was returned for additional testing.Root cause of tip breakage is applying power when not at the treatment site.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
Event or Problem Description
In this event it is reported that a proultra endo tip #3 pack broke during use.Reportedly, the tip broke at the lowest setting out of the patient's mouth.No injury occurred.

• Brand Name: PROULTRA ENDO TIP #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: 24984050
• Report Number: 2320721-2026-00059
• Device Sequence Number: 10491102
• Product Code: ELC
• UDI-Device Identifier: D716PUENDO31
• UDI-Public: D716PUENDO31
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Report Date (Section B): 04/24/2026

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: PUENDO3
• Device Lot Number: 0000453817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown