MAUDE Adverse Event Report: 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 that an eddy irrigation tip broke during treatment.All broken pieces were retrieved and no injury resulted.

Manufacturer Narrative

No smooth breakages; melted; breakages due to thermal influences.Misuse.Tip 1: cavi 2.Passive part broken at approx.25 mm point, active part measuring approx.21,60mm.Part in between is missing.No further broken parts received.Tip 2: cavi 3.Passive part broken at approx.28 mm point, active part measuring 21,90 mm.Part in between is missing.No further broken parts received tip 3: cavi 4.Passive part broken at approx.28 mm point, active part measuring 21,88 mm.Part in between is missing.No further broken parts received.All measured with measuring gauge mitutoyo cd-15 cpx valid till 06/2021.

• Brand Name: EDDY IRRIGATION TIP
• Type of Device: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• MDR Report Key: 11383075
• MDR Text Key: 239364395
• Report Number: 9611053-2021-00035
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 313986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1