MAUDE Adverse Event Report: DUAL CHAMBER SYRINGE SEALER; RESIN, ROOT CANAL FILLING

Catalog Number RIBBON

Device Problems Excess Flow or Over-Infusion (1311); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

While there is no indication that the thermaseal used malfunctioned, because this event may result in permanent damage to a body function/structure, this event meets the criteria for reportability 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

In this event it was reported that thermaseal ribbon sealer extruded past a patient's apex, and the patient was feeling pain.Procedure was completed and patient was referred to endodontist.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: DUAL CHAMBER SYRINGE SEALER
• Type of Device: RESIN, ROOT CANAL FILLING
• MDR Report Key: 10519104
• MDR Text Key: 207520276
• Report Number: 2320721-2020-00127
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• PMA/PMN Number: K960548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RIBBON
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1