MAUDE Adverse Event Report: DENTSPLY DENTSPLY CAVITRON; SCALER, ULTRASONIC

Model Number 4317 30K FSI-SLI-10S-GK

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2018

Event Type  Injury  

Event Description

Used dentsply 4317 30k fsi-sli-10s-gk green cavitron on distal lingual of #19.Removed out of pt's mouth to suction and noticed the tip of cavitron was missing.About 7-10 mm of tip was broken off.Pt was sent to acute care to have chest x-ray to make sure tip was not lodged in lung or other organ.Pt did swallow tip, was found on chest x-ray lodged in duodenum.Pt will return in a week to see if tip was removed from body naturally.

• Brand Name: DENTSPLY CAVITRON
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY; york PA 19404
• MDR Report Key: 7214897
• MDR Text Key: 98227486
• Report Number: MW5074759
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2018

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 Model Number: 4317 30K FSI-SLI-10S-GK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 64