ELEVATOR 3714383 GORNEY SUCTION 3MM TIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-09 for ELEVATOR 3714383 GORNEY SUCTION 3MM TIP manufactured by Integra York, Pa Inc..

Event Text Entries

[30836921] The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


[30836922] Customer initially reports surgeon using instrument during procedure, it broke at handle, tubing junction. On (b)(6) /2015 customer reports surgeon was performing a balloon sinuplasty to decrease size of the turbinates. Instrument broke in half and scratched the patients lip, no other harm done, no treatment necessary.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2015-00113
MDR Report Key5212039
Report SourceUSER FACILITY
Date Received2015-11-09
Date of Report2015-10-23
Date Mfgr Received2015-10-23
Date Added to Maude2015-11-09
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 ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELEVATOR 3714383 GORNEY SUCTION 3MM TIP
Generic NamePFM11
Product CodeKAD
Date Received2015-11-09
Catalog Number3714383
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-09

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