MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEM; SCALER, ULTRASONIC

Model Number G120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tinnitus (2103)

Event Type  malfunction  

Manufacturer Narrative

Therefore, because this event required medical intervention, it is reportable per 21 cfr part 803.Dhr review is not required because the product is outside of useful life.

Event Description

While using a g120 scaler, one patient was complaining that his ears are ringing after procedure with a cavitron g120 scaler.Medical assistance was sought with various physicians to get rid of ringing.The procedure happened about 7 months ago but patient has been back since for cleaning.

• Brand Name: CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEM
• 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: 8700795
• MDR Text Key: 148163316
• Report Number: 2424472-2019-00098
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970342
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G120
• Device Catalogue Number: G120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/14/2019
• 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