GYNECARE X-TRACT MORCELLATOR DV0015

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 2005-08-19 for GYNECARE X-TRACT MORCELLATOR DV0015 manufactured by Ethicon, Inc..

Event Text Entries

[14865423] The patient underwent a laparoscopic myomectomy in 2005. During the procedure, the handpiece blade became detached from the device, and the surgeon made a minor incision to retrieve the tissue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2005-00501
MDR Report Key628478
Report Source01,07
Date Received2005-08-19
Date of Report2005-07-22
Date of Event2005-07-16
Date Facility Aware2005-07-16
Report Date2005-07-22
Date Mfgr Received2005-07-22
Date Added to Maude2005-08-23
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 P.O. BOX 151
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182326
Manufacturer G1ACCELENT
Manufacturer Street45 LEXINGTON DRIVE
Manufacturer CityLACONIA NH 03246
Manufacturer CountryUS
Manufacturer Postal Code03246
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameGYNECARE X-TRACT MORCELLATOR
Generic NameMORCELLATOR
Product CodeHFG
Date Received2005-08-19
Returned To Mfg2005-09-02
Model NumberNA
Catalog NumberDV0015
Lot NumberMS0305046
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key618106
ManufacturerETHICON, INC.
Manufacturer AddressROUTE 22 WEST P.O. BOX 151 SOMERVILLE NJ 088760151 US
Baseline Brand NameGYNECARE LAPAROSCOPIC MORCELLATOR
Baseline Generic NameLAPAROSCOPIC MORCELLATOR
Baseline Model NoNA
Baseline Catalog NoDV0015
Baseline IDNA
Baseline Device FamilyGYNECARE LAPAROSCOPIC MORCELLATOR
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK963872
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-08-19

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