MAUDE Adverse Event Report: POWER MORCELLATOR

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/14/2007

Event Type  Injury  

Event Description

In (b)(6) 2007, i had a laparoscopic myomectomy which turned into a hysterectomy during the surgery.A power morcellator was used during the procedure.In (b)(6), i developed a lump underneath the left laparoscopic port site.I was told by drs that it was likely a lipoma and nothing to worry about.Because the lump seemed to be getting bigger, in (b)(6) 2015, i urged my dr to test it.We did a routine ct scan in (b)(6) 2016 and a biopsy in (b)(6) 2016.In (b)(6) 2016, it was determined that i had leiomyosarcoma.From (b)(6) to (b)(6), i underwent treatment for stage iiib or stage iv leiomyosarcoma (tumor was 8cm), including six rounds of chemotherapy, 28+ radiation treatment, and major surgery to remove the tumor.Thankfully, we got clear margins during surgery.I think the stage is now iiib because the secondary sites in my lungs do not seem to be growing and are too small to biopsy at this moment.

• Brand Name: POWER MORCELLATOR
• Type of Device: POWER MORCELLATOR
• MDR Report Key: 6666818
• MDR Text Key: 78472172
• Report Number: MW5070620
• Device Sequence Number: 0
• Product Code: HET
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 37 YR
• Patient Weight: 85