MAUDE Adverse Event Report: DENTSPLY LLC 30K FOCUSED SPRAY POWERLINE FITGRIP ULTRASONIC INSERT-1000; SCALER, ULTRASONIC

Catalog Number 82004

Device Problems Break (1069); Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

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.The covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

While using a 30k fsi-pwr-1000 insert, the cavitron was heating up consistently and the tip broke while in use, the dentist had to remove the broken section form the gum line but the patient required no additional medical treatment.

Manufacturer Narrative

Visually inspected and verified insert temperature is 87.0 meets spec.Insert does not get hot.Insert has a tip fracture after the edm hole towards the tip.

• Brand Name: 30K FOCUSED SPRAY POWERLINE FITGRIP ULTRASONIC INSERT-1000
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york, pa
• MDR Report Key: 10370953
• MDR Text Key: 201891970
• Report Number: 2424472-2020-00041
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82004
• Device Lot Number: 19024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/16/2020
• Patient Sequence Number: 1