MAUDE Adverse Event Report: DENTSPLY LLC 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC

Catalog Number 82005

Device Problems Loose or Intermittent Connection (1371); Overheating of Device (1437)

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 an overheating insert 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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

While the customer was using a 30k fsi-fg-10s insert, they allege that the cavitron tip is loose so just spins, and also gets very hot; no injury resulted.

Manufacturer Narrative

Tested on: g-137 40 psi gage id 9876 due: 07/31/2019 vibration: meets spec.Water flow: low water flow does not meet spec.Spray pattern: meets spec.Stack condition: meets spec.Tip condition: meets spec.Grip condition: loose nozzle grip assembly.(insert grip area spins around connecting body) does not meet spec.Inductance: meets spec: 3.12.Other visual observation: visually inspected and verified the insert has water and vibration.The insert was tested on a digital thermometer gauge # 6116 due date: 07/31/19.The temperature is 95.0 degrees meets spec.Specification states not to exceed 118.4° f.(per frs-9175 rev.8.) product is out of useful life.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10S STRAIGHT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 7848379
• MDR Text Key: 119499855
• Report Number: 2424472-2018-00133
• 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: 10/10/2018

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: 82005
• Device Lot Number: 17122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1