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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE BUR, EAR, NOSE AND THROAT

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MEDTRONIC XOMED INC. XPS® BLADE BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1884005HRE
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/01/2016
Event Type  malfunction  
Manufacturer Narrative
Corrected information: sex, no eval explain code. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The product has been returned, evaluation is in progress.
 
Event Description
It was reported that serrated jaws of the silver bullet blade broke off while in use. One side of the saw tip broke off. Fragments were retrieved successfully from the patient. There was no patient impact.
 
Manufacturer Narrative
Product analysis details: visually, the tip of the inner cutter broke off which would have resulted in the reported event. The tip measured approximately 0. 21¿ long. The break point corresponds to the first proximal valley of the inner blade teeth. There were no signs of excess pressure being applied during use or improper loading of the blade into the handpiece. The deformation of the break is consistent with the inner tip contacting the outer tip during use. There was no indication another device caused or contributed to this event. Although the final assembly is performed by manufacturing the configuration of the inner cutter and outer tube is a supplied material component. For this break to occur, the tip(s) configuration would have had to be misshapen. The information likely indicates the configuration of the raw material tips resulted in the breakage. Note ¿ verification of conformance to the raw material specification is not probable due to the impact between the inner in outer assemblies during use.
 
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Brand NameXPS® BLADE
Type of DeviceBUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL
Manufacturer Contact
amy corrales
6743 southpoint drive north
jacksonville, FL 32216
9043328138
MDR Report Key5526654
MDR Text Key102505529
Report Number1045254-2016-00084
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2019
Device Model Number1884005HRE
Device Catalogue Number1884005HRE
Device Lot Number0209906203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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