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

Catalog Number DV0015

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the patient underwent a laparoscopic myomectomy on unknown date.During the procedure, the blade would not rotate prior to first use.Another like device was used to complete the procedure.No adverse patient consequences were reported.

Manufacturer Narrative

(b)(4) - blade will not rotate prior to first use.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

This event does not meet serious injury or malfunction reporting criteria.This event is therefore not reportable.

• Brand Name: GYNECARE X-TRACT 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): ETHICON INC. - ACCELLENT; 45 lexington dr; laconia NH 03246
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3759285
• MDR Text Key: 4550533
• Report Number: 2210968-2014-05040
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993801
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DV0015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2014
• 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 Sequence Number: 1