MAUDE Adverse Event Report: DENTSPLY LLC 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER); SCALER, ULTRASONIC

Catalog Number 81570

Device Problems Restricted Flow rate (1248); Overheating of Device (1437); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where lack of water flow has caused an overheating insert.Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.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

While using a 30k fsi-sli-1000 insert, there was a stack or water flow issue producing extra heat within the sterimate.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Visually inspected and verified the insert has water and vibration meets spec.The insert was tested on a digital thermometer gauge # 6116 due date: (b)(6) 2021.The temperature is 84.2° degrees meets spec.Specification states not to exceed 118.4° f.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER)
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 10881542
• MDR Text Key: 218679768
• Report Number: 2424472-2020-00071
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

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: 81570
• Device Lot Number: 00044471
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1