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

Catalog Number 80395

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Per condition #1 in fda exemption # (b)(4), events where breakage of a cavitron insert tip meet the definition of a serious injury must be reported.Therefore, because this event necessitated medical intervention, it is reportable 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.

Event Description

While using a 30k fsi-sli-10s insert, the tip broke during a procedure and was swallowed by the patient.An x-ray and at least two colonoscopies were done.The patient has not yet passed the broken piece.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 8587954
• MDR Text Key: 147332369
• Report Number: 2424472-2019-00071
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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: 80395
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 06/09/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1