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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC

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ETHICON, INC. GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC 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 03/27/2013
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Conclusion: the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Manufacturer Narrative
Conclusion: the actual device involved in this event was returned for evaluation. The device was visually and functionally evaluated. The blade failed to rotate during the evaluation; it is likely that the accumulation of blood, body fluids, and tissue prevented the device from continuing to operate as intended.
 
Event Description
It was reported that a patient underwent a laparoscopic oophorectomy on (b)(6) 2013. During the procedure, the device worked properly at first. After that, the device did not activate properly during use. Another like device was used to complete the procedure with no adverse patient consequences.
 
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Type of DeviceLAPAROSCOPE, GYNECOLOGIC
Manufacturer (Section D)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876
Manufacturer (Section G)
THE MEDTECH GROUP INC.
6 century road
south plainfield NJ 07080
Manufacturer Contact
kathy rice
4545 creek road
mail location 120
cincinnati, OH 45242
5133373299
MDR Report Key3070318
MDR Text Key10715669
Report Number2210968-2013-04206
Device Sequence Number1
Product Code HET
Combination Product (y/n)N
Reporter Country CodeJA
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/30/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2013
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMX0100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2013
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/27/2013
Event Location Hospital
Date Manufacturer Received06/27/2013
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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