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 Fibrosis (3167)

Event Date 07/01/2006

Event Type  Injury  

Manufacturer Narrative

There was no indication of any malfunction of the device.

Event Description

Allegedly, the patient underwent a supracervical hysterectomy on (b)(6) 2006 at (b)(6), and after the procedure, a pathological examination revealed the mass was a leiomyoma.In (b)(6) 2014, due to irregular bleeding, the patient underwent an ultrasound and mri and was found with a supracervical mass.A subsequent operation found parasitic myoma growths on the right fallopian tube.

Manufacturer Narrative

During the discovery process of the litigation, it was determined that a karl storz product was not used during this subject adverse event.Device not returned for evaluation.

Event Description

Allegedly, the patient underwent a supracervical hysterectomy on (b)(6) 2006 at (b)(6), and after the procedure, a pathological examination revealed the mass was a leiomyoma.In (b)(6) 2014, due to irregular bleeding, the patient underwent an ultrasound and mri and was found with a supracervical mass.A subsequent operation found parasitic myoma growths on the right fallopian tube.

• 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, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 5136121
• MDR Text Key: 27833425
• Report Number: 9610617-2015-00078
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• 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
• 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): Other