GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCT GYNXMCUNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-01-11 for GYNECARE X-TRACT MORCELLATOR UNKNOWN PRODUCT GYNXMCUNK manufactured by Ethicon Inc..

Event Text Entries

[132904676] (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. It is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator. The event investigation is ongoing. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. How are you currently feeling? If in your possession, may we have a copy of your operative report? Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? If so, please provide your surgeon? S name, contact information and sign release of medical information form attached. Note: patient-reported adverse event of abdominal tumor diagnosed in 2014, abdominal open incision surgery for removal of the mass and leiomyoma as pathology results was reported via 2210968-2019-78354. Patient-reported adverse event of the new diagnosis which requires an open incision abdominal surgery with removal of cervix, fallopian tubes, ovaries, lymph nodes, appendix along with recession of bowels was reported via 2210968-2019-78366. 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.
Patient Sequence No: 1, Text Type: N, H10


[132904677] It was reported that the patient underwent a laparoscopic hysterectomy in 2006 and the morcellator was used. In 2014, the patient was diagnosed with an abdominal tumor and underwent an abdominal open incision surgery for removal of the mass. The pathologist report results were leiomyoma. In (b)(6) 2018, the patient was diagnosed with three abdominal tumors. Another open incisional surgery is scheduled, and primary diagnosis is disseminated leiomyomatosis. It was also reported that after the hysterectomy, ct scan shows that most of masses are located at the port site areas. The new diagnosis requires an open incision abdominal surgery with removal of cervix, fallopian tubes, ovaries, lymph nodes, appendix along with recession of bowels. The physician opined that the patient's tumors are the result of the morcellator. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2019-78367
MDR Report Key8242653
Report SourceCONSUMER,OTHER
Date Received2019-01-11
Date of Report2018-12-20
Date of Event2018-11-09
Date Mfgr Received2019-03-05
Date Added to Maude2019-01-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 X-TRACT MORCELLATOR UNKNOWN PRODUCT
Generic NameLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Product CodeHET
Date Received2019-01-11
Catalog NumberGYNXMCUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2019-01-11

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