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

Catalog Number G139

Device Problems Restricted Flow rate (1248); Overheating of Device (1437)

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

Event Type  malfunction  

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.

Event Description

While the customer was using a cavitron integrated system built in ultrasonic scaler g139 they allege that the insert gets really hot with little water.No injury was reported from the alleged event.

Manufacturer Narrative

G139-27042 rev11.Emh hp;cable,conn/gun cable damaged.Hp cable and 360 hp received for evaluation.Unit works fine but the hp cable has exposed wires and the water regulator is partially clogged causing poor water flow, 360 hp has a bent pin.Replaced the listed parts, checked for performance, cleaned and final test.

• Brand Name: CAVITRON INTEGRATED SYSTEM BUILT IN 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18317728
• MDR Text Key: 330372648
• Report Number: 2424472-2023-00060
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00388001041
• UDI-Public: D00388001041
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/04/2024

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: G139
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 01/04/2024
• 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