ENTACT SEPTAL STAPLER, 3-PACK 601-00100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for ENTACT SEPTAL STAPLER, 3-PACK 601-00100 manufactured by Arthrocare Corp..

Event Text Entries

[49160390] .
Patient Sequence No: 1, Text Type: N, H10


[49160391] It was reported that during a procedure using the entact septal stapler, the doctor alleged that the staples would not seat in the mucosa. The doctor opted to complete the procedure using a backup device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[50920976] The device was tested and upon squeezing of the trigger using a test pad, a staple was deployed as intended; therefore, the device performed as intended. The complaint could not be verified as the returned device performed as intended. The root cause could not be determined with confidence as several factors could contribute to the reported event. It is possible that an attempt was made to staple thick or hard tissue, placing the staple at the edge of cartilage, or an attempt to staple tissue in a constrained anatomical area which prevents the stapler arms from opening completely. The instructions for use for the device contains warning and precautionary measures regarding use of the device. A review of the manufacturing records for the device found no deficiencies associated with the alleged event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006524618-2016-00154
MDR Report Key5759954
Date Received2016-06-29
Date of Report2016-06-16
Date of Event2016-06-16
Date Mfgr Received2016-06-16
Date Added to Maude2016-06-29
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 ContactJIM GONZALES
Manufacturer Street7000 W WILLIAM CANNON
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer G1ARTHROCARE CORP.
Manufacturer Street7000 W. WILLIAM CANNON
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal Code78735
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENTACT SEPTAL STAPLER, 3-PACK
Generic NameSPLINT, INTRANASAL SEPTAL
Product CodeLYA
Date Received2016-06-29
Returned To Mfg2016-06-23
Catalog Number601-00100
Lot Number501039
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTHROCARE CORP.
Manufacturer Address7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-29

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