MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL 30K FOCUSED SPRAY POWERLINE ULTRASONIC INSERT - 1000; SCALER, ULTRASONIC

Catalog Number 80799

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Unspecified Infection (1930); Burn, Thermal (2530)

Event Date 10/17/2017

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

While using a 30k fsi-pwr-1000 insert, the insert was overheating and burned a patient's mucosa.Stomatitis was expected when burning occurred so the patient received medication.Stomatitis developed after a few days.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: 30K FOCUSED SPRAY POWERLINE ULTRASONIC INSERT - 1000
• 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: 7029622
• MDR Text Key: 91959976
• Report Number: 2424472-2017-00216
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052334
• 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: 12/18/2017

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 Catalogue Number: 80799
• Device Lot Number: 17191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 12/18/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention