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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MORCELLEX TISSUE MORCELLATOR; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

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ETHICON INC. GYNECARE MORCELLEX TISSUE MORCELLATOR; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) Back to Search Results
Catalog Number MX0100
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2013
Event Type  malfunction  
Event Description
It was reported that a patient underwent a gynecological procedure on (b)(6) 2013.During the procedure, the device stopped working.Another like device was used to complete the procedure with no adverse patient consequences.
 
Manufacturer Narrative
(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
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Brand Name
GYNECARE MORCELLEX TISSUE MORCELLATOR
Type of Device
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
MEDTECH GROUP INC
6 century ln
south plainfield NJ 07080
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key3846049
MDR Text Key4614275
Report Number2210968-2014-07044
Device Sequence Number1
Product Code HET
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K100280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2015
Device Catalogue NumberMX0100
Device Lot NumberMT218163
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/13/2014
Initial Date FDA Received06/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/13/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/03/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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