FORCEPS MCO13C ALLIG 3X0.6MM 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 MCO13C ALLIG 3X0.6MM HARTMAN manufactured by Medtronic Xomed Instrumentation S.a.s..

Event Text Entries

[18869071] The device (part#: mco13c) was returned to mxi service and repair.
Patient Sequence No: 1, Text Type: D, B5


[19291399] (b)(4). Eval of this device indicated that the pin was broken and replaced. The pin was most likely broken as a result of excessive force. 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 to 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 Number9680837-2013-00128
MDR Report Key3337539
Report Source01,07
Date Received2013-08-29
Date of Report2010-11-15
Date of Event2010-11-15
Date Mfgr Received2010-11-15
Device Manufacturer Date2009-09-01
Date Added to Maude2013-11-29
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 DR N
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 MCO13C ALLIG 3X0.6MM HARTMAN
Product CodeKAE
Date Received2013-08-29
Returned To Mfg2010-11-15
Model NumberMCO13C
Lot Number200909MF6
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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