MAUDE Adverse Event Report: DENTSPLY VDW GMBH EDDY IRRIGATION TIP; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Catalog Number V041441000000

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21cfr 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 a customer reported several eddy irrigation tip broke during treatment.Exact numbers of patients unknown at the moment.For this reported case, no injury resulted and no broken part remained in root canal.

Manufacturer Narrative

No smooth breakage.Melted, breakage due to thermal influence.Misuse.

• Brand Name: EDDY IRRIGATION TIP
• Type of Device: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12671785
• MDR Text Key: 280059314
• Report Number: 9611053-2021-00340
• Device Sequence Number: 1
• Product Code: EIC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041441000000
• Device Lot Number: 259925
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1