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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDDY IRRIGATION TIP; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
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EDDY IRRIGATION TIP; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING Back to Search Results
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.This report is for the first device.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
In this event a customer reported that two eddy irrigation tips were broken at one patient.The broken parts were removed and tooth filled and treatment concluded.
 
Manufacturer Narrative
No smooth breakage, melted.Breakage due to thermal influence - misuse.10 tips are following cavi numbers: 1, 3, 4 and 2.Nothing unusual to report was found during dhrs review.
 
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Brand Name
EDDY IRRIGATION TIP
Type of Device
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
MDR Report Key11553452
MDR Text Key243113209
Report Number9611053-2021-00084
Device Sequence Number1
Product Code EIC
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041441000000
Device Lot Number323749
Was Device Available for Evaluation? Yes
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 Number1
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