MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA INC. UNIDRIVE; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number 20711120

Device Problem Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Date 10/07/2013

Event Type  Injury  

Event Description

A total laparoscopic hysterectomy with morcellation of presumed uterine fibroids was performed.The patient was later found to have uterine leiomyosarcoma (via pathology) with evidence of metastasis 5 months after surgery.

• Brand Name: UNIDRIVE
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 5418687
• MDR Text Key: 37732244
• Report Number: 5418687
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 20711120
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 40 YR