MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON SELECT ULTRASONIC SCALER; SCALER, ULTRASONIC

Model Number G121

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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 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 cavitron g121 scaler, the insert was heating up.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

The device was evaluated and found to be within specification.Also, a dhr review was conducted with no discrepancies noted.

• Brand Name: CAVITRON SELECT ULTRASONIC SCALER
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6182905
• MDR Text Key: 62961980
• Report Number: 2424472-2016-00097
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

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 Model Number: G121
• Device Catalogue Number: G121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1