XPS? BLADE 1884012HR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-02 for XPS? BLADE 1884012HR manufactured by Medtronic Xomed Inc..

Event Text Entries

[173701180] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[173701181] 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.
Patient Sequence No: 1, Text Type: D, B5


[183433156] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183433157] On follow-up, it was reported that the broken piece was under observation to be passed out by the patient per rectum.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1045254-2020-00004
MDR Report Key9537825
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-02
Date of Report2020-02-21
Date of Event2019-12-11
Date Mfgr Received2020-02-20
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTY CAIN
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328353
Manufacturer G1MEDTRONIC XOMED INC.
Manufacturer Street6743 SOUTHPOINT DR N
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXPS? BLADE
Generic NameBUR, EAR, NOSE AND THROAT
Product CodeEQJ
Date Received2020-01-02
Returned To Mfg2020-01-15
Model Number1884012HR
Catalog Number1884012HR
Lot Number0217663583
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INC.
Manufacturer Address6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-02

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