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

Catalog Number MX0100R

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 02/03/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2014.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.

Manufacturer Narrative

(b)(4).The actual device was received for evaluation.The blade failed to rotate/advance during the evaluation.It is likely that the molten cable gear was likely the reason the device malfunctioned or stopped operating.One additional factor discovered during the evaluation that would have caused blade failure was the accumulation of blood, body fluids, and tissue between the blade and the sheaths.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• 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: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3655577
• MDR Text Key: 4318441
• Report Number: 2210968-2014-01855
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100280
• Number of Events Reported: 1
• 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: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: MX0100R
• Device Lot Number: MT218530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1