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

Catalog Number PUSURG5

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.Customer returned one broken pusurg5 from lot number 0000171025, batch number 0000167968.Visual testing of instrument performed using microscope.No defects or markings were noted on instrument.Recommended power settings for the pusurg5 are a minimum setting of 1 and a maximum power setting of 7.Also, these tips should be used with water.Several factors may contribute to breakage of tip, such as, intensity and pressure, correct technique and power settings.All of these factors may affect the longevity of the tip.Root cause of breakage is unknown.

Event Description

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

• Brand Name: PROULTRA SURGICAL 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: 8186833
• MDR Text Key: 131341638
• Report Number: 2320721-2018-00185
• 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: 12/20/2018

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: PUSURG5
• Device Lot Number: 0000171025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/20/2018
• 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