MAUDE Adverse Event Report: DENTSPLY LLC SELECT SPS SWVL/RESRV,230VUK/I; SCALER, ULTRASONIC

Catalog Number 81311

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

In this event it is reported that cavitron select sps (b)(6).Select sps swvl/resrv, 230vuk/i allegedly got hot and caused a burn and blister to patient's lip.The outcome of this event is unknown as of this mdr.Note: all components have been requested to be sent returned as we suspect this may be a worn insert issue rather than the scaler itself.

Manufacturer Narrative

Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability 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

Dhr review is not required because the product was returned for evaluation and the customer complaint is a known hazard.Based on the repair notes, the service technician was unable to duplicate the failure as stated in the complaint.Recommended repairs were made as part of preventive maintenance for continued system operation.Failure mode: overheating insert.Root cause: no defect proven.Conclusion code: no failure found.Additional information: unit set up.Customer has advised that a patients lip was burned during a procedure, customer has included 2 inserts but one was a non ds product (deldent) and this insert was not tested as this is not a ds specification product and should not be used in a ds scaler.The ds insert that the customer did supply was temperature tested at the tip with the unit powered to maximum which gave a reading of 25.8 to 26.0 degrees celsius which is not sufficiently high to cause harm but the insert was very old with the stack flexing very easily.Handpiece lead was also tested for continuity with out test sterimate (customer did not supply there own sterimate) which passed with nominal resistance in the handpiece.Repair and calibration checks carried out, unit running ok with worn/non spec inserts as the primary cause of this issue.

• Brand Name: SELECT SPS SWVL/RESRV,230VUK/I
• 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: 18596585
• MDR Text Key: 335075603
• Report Number: 2424472-2024-00356
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D003813021
• UDI-Public: D003813021
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: 81311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/24/2024
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1