MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

Model Number 26711101-1

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

Patient Problem Cancer (3262)

Event Date 12/06/2010

Event Type  Injury  

Manufacturer Narrative

There was no indication of any malfunction of the device.The device was not returned.

Event Description

Allegedly, the patient underwent a laparoscopic total hysterectomy in which a morcellator was used, and she was subsequently diagnosed with leiomyosarcoma.

• Brand Name: UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM
• Type of Device: MORCELLATOR
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen
• Manufacturer (Section G): KARL STORZ GMBH & CO, KG; mittlestrasse 8; 78503; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6671963
• MDR Text Key: 78542650
• Report Number: 9610617-2017-00049
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/20/2017

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?: No
• Device Operator: Physician
• Device Model Number: 26711101-1
• Device Catalogue Number: 26711101-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 33 YR