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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 Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problems Sinus Perforation (2277); Unspecified Tissue Injury (4559)
Event Type  malfunction  
Manufacturer Narrative
Therefore, because this event resulted in a serious injury, it is reportable per 21 cfr 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
It was reported that a dentist had an overinstruementation with reciproc blue file.They were over the apex, possibly caused a maxillarus sinus injury.Reply from dentist.Treatment of emphysema due to the over-instrumentation became necessary.The date for the root filling is still uncertain as the emphysema treatment has to be completed first.
 
Manufacturer Narrative
The involved reciproc blue file r25 8/100 25mm 025 was returned in loose.After analysis, no visual damage was observed.Moreover, the active part is matching to the drawing (d3 and d13).No fault was found.Returned instrument meets specifications.For information, nothing unusual to report was found during dhrs review (batches #1643331, #1643322, #1643325 #1643329 and #1643324).
 
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Brand Name
RECIPROC BLUE FILES, 6X, STERILE
Type of Device
FILE, PULP CANAL, ENDODONTIC
MDR Report Key11611725
MDR Text Key244887199
Report Number9611053-2021-00107
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 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV040252025025
Device Lot Number325380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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