FORCEPS MCO21 DIA 1.0MM 70MM CUP [MXI]

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-28 for FORCEPS MCO21 DIA 1.0MM 70MM CUP [MXI] manufactured by Medtronic Xomed Instrumentation S.a.s.

Event Text Entries

[18362368] The device (forceps mco21 dia 1. 0mm 70mm cup) was returned to mxi for service and repair. It was reported that the screw was missing
Patient Sequence No: 1, Text Type: D, B5


[18433397] (b)(4). Analysis of the device (forceps mco21 dia 1. 0mm 70mm cup) confirmed that the device is missing screw. It was also determined that the instrument was bent and would not lock into place. 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680837-2013-00418
MDR Report Key3314208
Report Source05,06
Date Received2013-08-28
Date of Report2011-03-29
Date of Event2011-03-29
Date Mfgr Received2011-03-29
Date Added to Maude2013-11-27
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 FDA0
Event Location0
Manufacturer ContactSHARANYA JANGITI
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328183
Manufacturer G1MEDTRONIC XOMED, INC.
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFORCEPS MCO21 DIA 1.0MM 70MM CUP [MXI]
Generic NameFORCEPS, ENT
Product CodeKAE
Date Received2013-08-28
Returned To Mfg2011-03-29
Model NumberMCO21
Catalog NumberMCO21
Lot NumberNOT PROVIDED
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2013-08-28

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