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

Catalog Number 82006

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4), events meeting the definition of a serious injury are reportable.Therefore, because this event resulted in medical intervention, thus meeting the definition of a serious injury, it is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

While using a 30k fsi-sli-fg-10l insert, the insert was broken at the tip while at the first tooth and the patient swallowed the broken piece.The patient was transmitted to the hospital where a gastroscopy was performed to remove the broken tip.The patient "has no discomforts anymore.".

Manufacturer Narrative

Evaluation confirmed the tip is broken.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10L LEFT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6977823
• MDR Text Key: 91095317
• Report Number: 2424472-2017-00136
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

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 Catalogue Number: 82006
• Device Lot Number: 5105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• 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