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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 1884012HR
Device Problem Material Separation (1562)
Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Event Date 12/11/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A health care provider (hcp) reported via a manufacturer representative that in the middle of a septoplasty procedure, the external tip of the product broke off and was first noticed by the nurse when she received it back from the surgeon. When the surgeon checked the nasal cavity, he could not find the tip. After an extensive search and laryngeal mask airway (lma) was removed, x-ray was done and confirmed that the missing tip was in the patient¿s stomach. A replacement device was used to finish the procedure. There was a 30-minute delay in the procedure as a result of this event. It was noted that the broken piece remained inside the patient's body. The patient was discharged from theatre.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On follow-up, it was reported that the broken piece was under observation to be passed out by the patient per rectum.
 
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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 32216
Manufacturer Contact
christy cain
6743 southpoint drive north
jacksonville, FL 32216
9043328353
MDR Report Key9537825
MDR Text Key173701180
Report Number1045254-2020-00004
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1884012HR
Device Catalogue Number1884012HR
Device Lot Number0217663583
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/02/2020 Patient Sequence Number: 1
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