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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 Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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 seventh 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 it was reported that eight eddy irrigation tips broke during use.The outcome of the event is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Multiple unsuccessful attempts were made to obtain the patient outcome.
 
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Brand Name
EDDY IRRIGATION TIP
Type of Device
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
MDR Report Key12036714
MDR Text Key260466914
Report Number9611053-2021-00193
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041441000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/21/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/12/2021
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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