MAUDE Adverse Event Report: MORCELLATOR; ENDOSCOPIC MORCELLATOR GASTROENTEROLOGY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fibrosis (3167)

Event Date 12/11/2018

Event Type  Injury  

Event Description

Ten years ago, i was diagnosed with fibroids in my uterus, the dr used the morcellator to remove it, but instead everything and tossed it through my whole body.December i had to have fibroids removed from my lungs, kidney and more.Two hysterectomies.Fda safety report id# (b)(4).

• Brand Name: MORCELLATOR
• Type of Device: ENDOSCOPIC MORCELLATOR GASTROENTEROLOGY
• MDR Report Key: 8555753
• MDR Text Key: 143462396
• Report Number: MW5086221
• Device Sequence Number: 1
• Product Code: PTE
• Combination Product (y/n): N
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 50 YR
• Patient Weight: 57