MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-PWR-1000 INSERT,PACKED; SCALER, ULTRASONIC

Catalog Number	80799
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/08/2024
Type of Reportable Event	Death
Event or Problem Description
In this event it is reported that a 30k fsi-pwr-1000 insert, packed broke during use and the patient swallowed the broken part.The patient was seen in the hospital, had imaging to determine location of the separated instrument, and it was retrieved in the or of the local hospital.
Additional Manufacturer Narrative
Since this event 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.
Additional Manufacturer Narrative
Dhr: dhr was reviewed and everything meet specification.No deviation found.Insert did not receive.Base on investigation product was in bul.Failure mode - broken tip.Root cause - unexpected failure type.Conclusion code - unexpected failure.
Event or Problem Description
Additional information was received indicating that the patient involved in this incident died due to cardiac arrest.The patient's spouse reported that the patient died on (b)(6) 2024.The spouse reported that the patient had complications from the surgery to remove the broken piece of the device that was ingested and was in and out of the hospital many times since the surgery.The spouse alleges, "i cannot begin to express to you the extreme pain and stress this has caused him, so much to the point he couldn¿t take it any longer.¿.

• Brand Name: 30K FSI-PWR-1000 INSERT,PACKED
• Common Device Name: 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: 18707578
• Report Number: 2424472-2024-00361
• Device Sequence Number: 8274261
• Product Code: ELC
• UDI-Device Identifier: D003807991
• UDI-Public: D003807991
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2024

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 Catalogue Number: 80799
• Device Lot Number: 00106163
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/12/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/15/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown