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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS QUADCUT BLADE; BUR, EAR, NOSE (BLADE)

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MEDTRONIC POWERED SURGICAL SOLUTIONS QUADCUT BLADE; BUR, EAR, NOSE (BLADE) Back to Search Results
Catalog Number 1884380HR
Device Problems Leak/Splash (1354); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2016
Event Type  malfunction  
Event Description
When using the shaver handpiece during a case after hooking it up, it was working just fine and then about 30 minutes into the case, there was saline leakage noted coming from the shaver handpiece and where it hooks up to the blade.Upon inspection, the shaver blade was separated into two pieces.Switched shaver handpieces and had same issues.Switched to a new blade with the original handpiece and it worked great.The drape got slightly wet from the leak but the patient was not harmed by the defective blade.
 
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Brand Name
QUADCUT BLADE
Type of Device
BUR, EAR, NOSE (BLADE)
Manufacturer (Section D)
MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 north beach st.
fort worth TX 76137
MDR Report Key5737717
MDR Text Key47811640
Report Number5737717
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/09/2016
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 Physician
Device Expiration Date01/10/2020
Device Catalogue Number1884380HR
Device Lot Number0210656191
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/09/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/21/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age22 YR
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