MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA SINE TIP #5; SCALER, ULTRASONIC

Catalog Number PUSINE5

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a proultra sine tip # 5 broke during use; no injury resulted and broken tip was retrieved.

Manufacturer Narrative

Customer returned one pusine5.Using microscope visually checked tip.Instrument was broken as indicated in complaint.No manufacturing defects or markings were noted on instrument.Dfu recommended power setting for the pusine5 are a minimum power setting of 1 and a maximum power setting of 3.Several factors may contribute to breakage of tips, such as number of uses, intensity, and pressure.All of these may affect the longevity of the tip.It is recommended that the tip be at treatment site before engaging power.Root cause of breakage cannot be determined.Nothing unusual to report was found during dhr review.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

• Brand Name: PROULTRA SINE TIP #5
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city, tn
• MDR Report Key: 9772463
• MDR Text Key: 191116535
• Report Number: 2320721-2020-00017
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K960889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

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 Operator: Health Professional
• Device Catalogue Number: PUSINE5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/29/2020
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1