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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RECIPROC BLUE FILES, 6X, STERILE; FILE, PULP CANAL, ENDODONTIC
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RECIPROC BLUE FILES, 6X, STERILE; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number V040252025025
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 permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.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 a reciproc blue broke during use; 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
RECIPROC BLUE FILES, 6X, STERILE
Type of Device
FILE, PULP CANAL, ENDODONTIC
MDR Report Key12671802
MDR Text Key280060815
Report Number9611053-2021-00341
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/03/2021
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 NumberV040252025025
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/20/2021
Initial Date FDA Received10/21/2021
Supplement Dates Manufacturer Received09/20/2021
Supplement Dates FDA Received11/03/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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