MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON JET PLUS ULTRASONIC SCALER AND AIR POLISHING PROPHYLAXIS SYSTEM; SCALER, ULTRASONIC

Model Number G137

Device Problem 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 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 21 cfr part 803.Evaluation found no issues with unit heating inserts.Water pressure was at 22 psi with water flow over 100 cc/min at maximum setting.All electrical calibration points are within calibration.Operated unit for extended period with no heat development of insert.Cleaned up tubing, replaced water filter and depleted foot control batteries along with tuning/calibration of unit, all functions tested.The customer was advised to evaluate inserts for damage/wear and recommend denstply inserts only.

Event Description

While using a cavitron g137 scaler, the insert was heating up; no injury resulted.

• Brand Name: CAVITRON JET PLUS ULTRASONIC SCALER AND AIR POLISHING PROPHYLAXIS SYSTEM
• 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: 6194381
• MDR Text Key: 63065112
• Report Number: 2424472-2016-00096
• Device Sequence Number: 1
• Product Code: ELC
• 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
• Report Date: 12/21/2016

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: G137
• Device Catalogue Number: 8187501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/21/2016
• 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