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U.S. Department of Health and Human Services

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

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MEDTRONIC XOMED INC. XPS® HANDPIECE - POWERFORMA® BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 3327700
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A healthcare provider (hcp) reported that the console was getting an error code 2 when using the handpiece during the functional endoscopic sinus surgery procedure. They tried to reboot the console and tried a new handpiece but neither option worked. The procedure was cancelled and the patient was under the anesthesia. There was no patient impact.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The healthcare provider confirmed that the adapter to the drill was the one giving them issues.
 
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Brand NameXPS® HANDPIECE - POWERFORMA®
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 32216
Manufacturer Contact
uriza shums
6743 southpoint drive north
jacksonville, FL 32216
9043328405
MDR Report Key8148450
MDR Text Key129834125
Report Number1045254-2018-00699
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3327700
Device Catalogue Number3327700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/10/2018 Patient Sequence Number: 1
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