GYNECARE MORCELLATOR DV0015 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-09 for GYNECARE MORCELLATOR DV0015 * manufactured by Ethicon, Inc..

Event Text Entries

[17802681] During a laparoscopic procedure, the physician used a morcellator. Even though the morcellator blade was not engaged, part of it was actually exposed and a vessel in the anterior abdominal wall was lacerated. The morcellator was removed and the area was sutured. A second morcellator was inserted and the procedure was completed. Treatment was required because of the device failure. The physician put 2 ligatures around the vessel. The patient's vital signs remained stable throughout the procedure and they were taken to the recovery room in good condition. Reportedly, the morcellator had a defective locking mechanism. The company representative was contacted and retrieved the defective equipment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 552553
• MDR Report Key: 552553
• Date Received: 2004-02-09
• Date of Report: 2004-02-09
• Date of Event: 2003-12-30
• Report Date: 2004-02-09
• Date Reported to FDA: 2004-02-09
• Date Added to Maude: 2004-11-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GYNECARE MORCELLATOR
• Generic Name: MORCELLATOR
• Product Code: LEC
• Date Received: 2004-02-09
• Model Number: DV0015
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 542103
• Manufacturer: ETHICON, INC.
• Manufacturer Address: ROUTE 22 WEST; PO BOX 151 SOMERVILLE NJ 088760151 US
• Baseline Brand Name: TENSION FREE VAGINAL TAPE
• Baseline Generic Name: MESH, SURGICAL, POLYMERIC
• Baseline Model No: NA
• Baseline Catalog No: 810081
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-02-09