FORCEPS MCO13A ALLIG 4X1.0MM HARTMAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-29 for FORCEPS MCO13A ALLIG 4X1.0MM HARTMAN manufactured by Medtronic Xomed Instrumentation S.a.s..

Event Text Entries

[3870023] The device (part#: mco13a) was returned to mxi service and repair.
Patient Sequence No: 1, Text Type: D, B5


[11180783] (b)(4). Evaluation of this device indicated that the palate of the mobile jaws was broken at the pin. The break area presented with superficial corrosion, but no material or manufacturing defects were identified. The most likely cause for the break was excess force during use or reprocessing. Note: this mdr is being filed as a result of an internal review of complaints from medtronic's mxi facility in (b)(4). This review was conducted in resolve several issues discovered in the mxi complaint handling process. Issues resolved include the misclassification of devices returned for repair, as well as gaps in reporting. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680837-2013-00398
MDR Report Key3337833
Report Source01,07
Date Received2013-08-29
Date of Report2013-03-14
Date of Event2013-03-14
Date Mfgr Received2013-03-18
Device Manufacturer Date2012-07-01
Date Added to Maude2013-12-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJONATHAN SCHLECH
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328355
Manufacturer G1MEDTRONIC XOMED INSTRUMENTATION S.A.S.
Manufacturer StreetLE PAVILLON
Manufacturer CitySAINT-AUBIN-LE-MONIAL 03160
Manufacturer CountryFR
Manufacturer Postal Code03160
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFORCEPS MCO13A ALLIG 4X1.0MM HARTMAN
Product CodeKAE
Date Received2013-08-29
Returned To Mfg2013-03-18
Model NumberMCO13A
Lot Number120708
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INSTRUMENTATION S.A.S.
Manufacturer AddressLE PAVILLON SAINT-AUBIN-LE-MONIAL 03160 FR 03160


Patients

Patient NumberTreatmentOutcomeDate
10 2013-08-29

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