MICROSPAN SYSTEM GMS805

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 2005-04-07 for MICROSPAN SYSTEM GMS805 manufactured by Ethicon, Inc..

Event Text Entries

[369657] The sheaths are splitting at the "10% angle" when ancillary instruments are introduced. The channel has been opened with the instruments prior to insertion into the patient but the sheath still splits when the instruments are introduced. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2005-00211
MDR Report Key590840
Report Source01,07
Date Received2005-04-07
Date of Report2005-03-08
Report Date2005-03-08
Date Mfgr Received2005-03-08
Date Added to Maude2005-04-14
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 ContactMR MARK YALE
Manufacturer StreetROUTE 22 WEST PO BOX 151
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182326
Manufacturer G1CONMED CORPORATION
Manufacturer Street310 BROAD ST
Manufacturer CityUTICA NY 13501
Manufacturer CountryUS
Manufacturer Postal Code13501
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameMICROSPAN SYSTEM
Generic NameSHEATH
Product CodeNIH
Date Received2005-04-07
Returned To Mfg2005-03-14
Model NumberNA
Catalog NumberGMS805
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key580696
ManufacturerETHICON, INC.
Manufacturer AddressROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 088760151 US
Baseline Brand NameMICROSPAN SYSTEM
Baseline Generic NameSHEATH
Baseline Model NoNA
Baseline Catalog NoGMS805
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2005-04-07

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