MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA SURGICAL TIP #1; SCALER, ULTRASONIC

Catalog Number PUSURG1

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 surgical tip #1 broke during use; no injury resulted.

Manufacturer Narrative

The customer returned a broken ultrasonic tip and empty packaging from a pusurg lot#0000237562.However, identification markings on the sides of the broken tip read "kis 2d" and "071", indicating it is a kerr tip.This tip is not manufactured by tds and has not been sold by dentsply sirona in some time.Root cause unknown.

• Brand Name: PROULTRA SURGICAL TIP #1
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 9533438
• MDR Text Key: 184461054
• Report Number: 2320721-2019-00267
• 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: 03/04/2020

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: PUSURG1
• Device Lot Number: 0000237562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1