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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 Problem 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 use.No injury reported.
 
Manufacturer Narrative
Two tips received in two pieces to share between three prs (b)(4).Tip 1: broken at 25 mm point of passiv part and at 22 mm point of active part.Part in between is missing.No smooth breakage; melted; breakage due to thermal influences.Tip cavi 3.Tip 2: broken approx.At 28 mm point of passive part; active part measuring approx.27,80mm no further broken parts received.Tip cavi 1.Measured with measuring gauge mitutoyo cd-15 cpx valid till 06/2021; no smooth breakages; melted; breakages due to thermal influences.Misuse.
 
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Brand Name
EDDY IRRIGATION TIP
Type of Device
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
MDR Report Key11396909
MDR Text Key239367232
Report Number9611053-2021-00043
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 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041441000000
Device Lot Number325215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2021
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 Number1
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