MAUDE Adverse Event Report: STORZ MORCELLATOR

Device Problem Insufficient Information (3190)

Patient Problem Cyst(s) (1800)

Event Date 12/16/2015

Event Type  Injury  

Event Description

Stolz power morcellator was used in a fibroid hysterectomy.One of the cysts morcellated and biopsied ended up growing dozens of cysts throughout my abdominal cavity requiring a major abdominal surgery and 4 days in the hospital, taking 4 1/2 hours to surgically remove all of the cysts.My omentum and an ovary.All covered in these cysts (identical make up as the one biopsied).There is a substantial chance the cysts will re-grow.

• Brand Name: MORCELLATOR
• Type of Device: MORCELLATOR
• Manufacturer (Section D): STORZ
• MDR Report Key: 5416694
• MDR Text Key: 37726155
• Report Number: MW5060043
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 59