MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-PWR-FG-100 INSERT,PKD; SCALER, ULTRASONIC

Catalog Number 82003

Device Problem Break (1069)

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  malfunction  

Event Description

In this event it is reported that a 30k fsi-pwr-fg-100 insert,pkd broke during use.It's been reported that the patient was injured during a scaling procedure due to a cavitron insert breaking off.They did have to go to the e.R.And also had to have a surgical procedure (what kind of procedure is unknown).The patient is ok,.

Manufacturer Narrative

There has been a previous report with this or a similar device where this malfunction caused or contributed to a serious injury or required medical/surgical intervention to preclude such.Therefore, this event meets the criteria for a reportable event per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Investigation: dhr was reviewed and everything meet specification.No deviation found.Insert not received.Root cause: unexpected failure type (ft0200).

• Brand Name: 30K FSI-PWR-FG-100 INSERT,PKD
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16173380
• MDR Text Key: 308827796
• Report Number: 2424472-2023-00341
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• 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,Followup
• Report Date: 05/10/2023

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 Catalogue Number: 82003
• Device Lot Number: 00060524
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/13/2023
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1