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

Catalog Number V041441000000

Device Problems Break (1069); Inaccurate Synchronization (1609)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.

Event Description

In this event a customer reported that an eddy irrigation tip broke; no injury resulted.

Manufacturer Narrative

1st tips with cavity 2; tips is missing 13.3mm measured from 28mm point.2nd tip cavity 4, broken in 2 pieces - nothing missing.Measuring gauge mitutoyo model # cd 15cpvalid to 5/2020.No smooth breakage, melted.Breakage due to thermal influence - misuse.Test of unused product passed the safety and mechanical test.No fault found on unused instruments.Nothing unusual to report was found during dhr review.

• Brand Name: EDDY IRRIGATION TIP
• Type of Device: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• MDR Report Key: 8596905
• MDR Text Key: 144846503
• Report Number: 9611053-2019-00129
• Device Sequence Number: 1
• Product Code: EIC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,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

• Date FDA Received: 05/09/2019
• 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: 244108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1