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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
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 one eddy irrigation tip broke during treatment.The outcome of the event is unknown as of this mdr evaluation.
 
Manufacturer Narrative
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.Additional information was received indicating that the broken portion of the device was removed from the patient's tooth.
 
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Brand Name
EDDY IRRIGATION TIP
Type of Device
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
MDR Report Key11429915
MDR Text Key240707742
Report Number9611053-2021-00060
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 Received03/07/2021
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
Date Manufacturer Received02/04/2021
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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