MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES PROULTRA ENDO TIP #7; SCALER, ULTRASONIC

Catalog Number PUENDO7

Device Problems Break (1069); Material Separation (1562)

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 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 21 cfr part 803.This report is for the first 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 pro ultra endo tips separated during use; no injury resulted.

Manufacturer Narrative

Customer returned 2 puendo7's in an autoclave bag.Using microscope visually checked tip.Both instruments were broken as indicated in complaint.No manufacturing defects or markings were noted on instruments.Complaint does not indicate what power setting was being used at time of breakage, only that it was not a p5 unit.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.Root cause of breakages can not be determined.A dhr review was conducted with no discrepancies noted.Also, a query indicates no additional complaints have been received for this serial/batch number.

• Brand Name: PROULTRA ENDO TIP #7
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5985857
• MDR Text Key: 56109053
• Report Number: 2320721-2016-00045
• 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: 12/08/2016

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: PUENDO7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• 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