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

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 09/25/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was received for evaluation.The complaint was on the main housing and only the trigger was returned.The trigger operated as intended during evaluation.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that a patient underwent a laparoscopic supracervical hysterectomy on (b)(6) 2013.During the procedure, the device blade kept stopping and starting.Another like device was used to complete the procedure with no adverse patient consequences.

Manufacturer Narrative

(b)(6).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.

• 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: 3655544
• MDR Text Key: 11562825
• Report Number: 2210968-2014-01851
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2014

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 Date: 07/31/2015
• Device Catalogue Number: MX0100
• Device Lot Number: MT218393
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 03/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2013
• 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