MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROULTRA ENDO TIP #4 PACK; SCALER, ULTRASONIC

Catalog Number PUENDO4

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

In this event it was reported that a proultra endo tip broke during use; no injury resulted.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.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 a proultra endo tip broke as soon as doctor started to use it.Tech emailed office to discover setting and job the tip was intended to be used for.I will replace tip this time and educate on settings on parameters and what each tip is used for.

Manufacturer Narrative

Evaluation of the returned device found it was broken as indicated in the complaint.A dhr review was conducted with no discrepancies noted.

• Brand Name: PROULTRA ENDO TIP #4 PACK
• Type of Device: 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 13111008
• MDR Text Key: 285333588
• Report Number: 2320721-2021-00113
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

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: PUENDO4
• Device Lot Number: 0000307037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/16/2021
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1