HOOK MCO205 165MM 0.3MM 90DEG

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 HOOK MCO205 165MM 0.3MM 90DEG manufactured by Medtronic Xomed Instrumentation S.a.s..

Event Text Entries

[3727967] The device (part#: mco205) was returned to mxi service and repair. "delivered instrument not compliant, no more hook, request for replacement. "
Patient Sequence No: 1, Text Type: D, B5


[11030055] (b)(6). Evaluation of this instrument indicated that the hook was broken. No fragment was found in the returned box. No trace of package damage (hole from hooks/impacts) could be observed. It was also very unlikely that the instrument could have been repackaged damaged. 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. Mxi capa (b)(4) was opened to address these issues. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680837-2013-00333
MDR Report Key3337889
Report Source01,07
Date Received2013-08-29
Date of Report2012-12-10
Date of Event2012-12-10
Date Mfgr Received2012-12-10
Device Manufacturer Date2012-10-01
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 NameHOOK MCO205 165MM 0.3MM 90DEG
Product CodeJYL
Date Received2013-08-29
Returned To Mfg2012-12-10
Model NumberMCO205
Lot Number121003
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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