MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON INTEGRATED BUILT-IN SYSTEM ULTRASONIC SCALER G139; SCALER, ULTRASONIC

Catalog Number 8800001

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

While the customer was using a cavitron integrated built-in system ultrasonic scaler g139 they allege that the handpiece and inserts are getting very warm.No injury was reported from the alleged event.

Manufacturer Narrative

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.

Manufacturer Narrative

Root cause is unknown as no product was returned by the customer after two attempts were made.This complaint will be closed but will be reopened if product is returned.

• Brand Name: CAVITRON INTEGRATED BUILT-IN SYSTEM ULTRASONIC SCALER G139
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 19175396
• MDR Text Key: 341037081
• Report Number: 2424472-2024-00032
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00388000011
• UDI-Public: D00388000011
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/24/2024

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: 8800001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1