MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON BUILT-IN WITH 82" SURF (TAN) CABLE AND STERI-MATE 360 HANDPIECE; SCALER, ULTRASONIC

Model Number G139

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

Therefore, because this event resulted in a serious injury, it is reportable per 21 cfr part 803.Multiple unsuccessful attempts were made to obtain the device for evaluation.

Event Description

While using a g139 scaler, in (b)(6) 2019 a patient was burned on the lingual of the lower anterior by the cavitron tip.The patient returned to the office at a later date and the result on the tissue was a cleft of several millimeters that required gingival grafting.The grafting was done by a periodontist, but neither the treating dentist or periodontist have seen the patient since.

• Brand Name: CAVITRON BUILT-IN WITH 82" SURF (TAN) CABLE AND STERI-MATE 360 HANDPIECE
• 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: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 11325811
• MDR Text Key: 232144912
• Report Number: 2424472-2021-00002
• 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: 02/12/2021

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 Model Number: G139
• Device Catalogue Number: 8800004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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