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

Catalog Number PUENDO5

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 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.This report is for the second device.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 Description

In this event it was reported that two proultra endo tips broke during use; no injury resulted.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The lot number provided cannot be found in our system.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

• Brand Name: PROULTRA ENDO TIP #5
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 9682102
• MDR Text Key: 191104101
• Report Number: 2320721-2020-00006
• 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: PUENDO5
• Device Lot Number: 0000240341
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1