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

Catalog Number 80396

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Per condition #1 of fda exemption #: (b)(4), events resulting in serious injury are reportable per 21cfr part 803.Visually inspected and confirmed insert has a tip fracture after the edm hole towards the tip does not meet spec.Insert is beyond useful life.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

While using a 30k sfi-sli-10l insert, the insert broke and the patient ingested the broken piece.The patient had initially gone to the emergency room to determine if he had swallowed or aspirated the broken tip.They determined he had swallowed it.They had him come back the next day and performed an endoscopy, but could not reach the broken tip.He came back again for an x-ray for them to follow its progress and determine that no damage had been done.The patient then passed the broken portion of the tip without any further complications.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10L LEFT
• 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: 10608111
• MDR Text Key: 209224695
• Report Number: 2424472-2020-00039
• 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: 09/30/2020

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: 80396
• Device Lot Number: 4337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 09/30/2020
• 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
• Patient Outcome(s): Required Intervention