MAUDE Adverse Event Report: DENTSPLY LLC 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC

Catalog Number 80395

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

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.Further investigation showed some material got inside the insert hole clogging the insert, and as a result, the insert was getting hot because of water flow restriction.This band was installed by the customer.The issue was due to material debris from the band installed by the user.No manufacturing problem was identified.Multiple unsuccessful attempts were made to obtain the patient outcome.

Event Description

While the customer was using a 30k fsi-sli-10s insert, it was running hot.The event outcome is unknown as of this mdr evaluation.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT
• 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: 9127018
• MDR Text Key: 186714832
• Report Number: 2424472-2019-00148
• 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: 09/26/2019

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 Catalogue Number: 80395
• Device Lot Number: 00031368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/26/2019
• 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