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

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Per user facility medwatch (b)(4).

Event Description

It was reported that the patient underwent fibroid resection with morcellation of tissue approximately eight and a half years ago.The patient was recently found to have an abdominal mass.The mass was resected and path revealed it was leiomyosarcoma.The abdomen may have been seeded from the morcellation of the fibroid.No additional information has been provided.

• Brand Name: GYNECARE MORCELLEX UNKNOWN PRODUCT
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7500017
• MDR Text Key: 107781907
• Report Number: 2210968-2018-72689
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR