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

Catalog Number PUENDO5

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

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.Customer returned one broken puendo5 from batch number 0000191766, and one broken puendo5 from lot number 0000195109.Using microscope visually checked tips.Instruments were broken as indicated in complaint.No manufacturing defects or markings were noted on instruments.Nothing unusual to report was found during the dhr review.Recommended power settings for the puendo5 are a minimum setting of 1 to a maximum setting of 4.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.

Event Description

In this event it was reported that two proultra endo tip #5 broke during use; no injury resulted.

• 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
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8196670
• MDR Text Key: 131493249
• Report Number: 2320721-2018-00192
• 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
• Report Date: 12/26/2018

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: 195109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1