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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MORCELLEX UNKNOWN PRODUCT

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ETHICON INC. GYNECARE MORCELLEX UNKNOWN PRODUCT Back to Search Results
Lot Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Iatrogenic Source (2498); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. Additional: it is unknown if the actual device used in this patient procedure was in fact an ethicon morcellator. The event investigation is ongoing.
 
Event Description
It was reported by an attorney that the patient underwent a laparoscopic supracervical hysterectomy for the removal of uterine fibroids on (b)(6) 2012 and a morcellator was utilized. On (b)(6) 2014, the patient was diagnosed with abdominal leiomyosarcoma, the cancer metastasized, and the patient died on (b)(6) 2015. No additional information was provided.
 
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Brand NameGYNECARE MORCELLEX UNKNOWN PRODUCT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
MEDTECH GROUP INC
6 century ln
south plainfield NJ 07080
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5678423
MDR Text Key45874812
Report Number2210968-2016-09225
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/17/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/25/2016 Patient Sequence Number: 1
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