GYNECARE MORCELLEX UNKNOWN PRODUCT GMORCUNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-30 for GYNECARE MORCELLEX UNKNOWN PRODUCT GMORCUNK manufactured by Ethicon Inc..

Event Text Entries

[146546379] (b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. The device information for use under precautions states" caution: the use of a laparoscopic tissue extraction bag is recommended for the morcellation of malignant tissue or tissue suspected of being malignant and for tissue that the physician considers to be potentially harmful when disseminated in a body cavity. As morcellation may affect endometrial pathologic examination, preoperative evaluation of the endometrium should be considered. Should malignancy be identified, use of the gynecare morcellex? Tissue morcellator may lead to dissemination of malignant tissue. Suspect medical device: it is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator. The event investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10


[146546380] It was reported by an attorney that the patient underwent a laparoscopic myomectomy and hysterectomy procedure in 2007 and the morcellator was used. It was also reported that the patient developed leiomyosarcoma. No further information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2019-82124
MDR Report Key8655592
Report SourceOTHER
Date Received2019-05-30
Date of Report2019-05-07
Date Mfgr Received2019-05-07
Date Added to Maude2019-05-30
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 ContactDARLENE KYLE
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone9082182792
Manufacturer G1ETHICON INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGYNECARE MORCELLEX UNKNOWN PRODUCT
Generic NameLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Product CodeHET
Date Received2019-05-30
Catalog NumberGMORCUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-30

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