MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGY; SCALER, ULTRASONIC

Model Number G136

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

There were no electrical issues found with the unit.As such, this event meets the criteria for reportability per 21 cfr part 803.

Event Description

While the customer was using a g136, they alleged that they were shocked.The information provided is not entirely clear as we received conflicting information on the alleged event and injuries.We believe the hygienist received a burn and is undergoing therapy.

• Brand Name: CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGY
• 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: joleta ness ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 12036706
• MDR Text Key: 257410767
• Report Number: 2424472-2021-00033
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G136
• Device Catalogue Number: 8184001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2021
• 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
• Patient Outcome(s): Required Intervention