UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

Report

• Report Number: 9610617-2015-00106
• Event Type: Death
• Date Received: December 14, 2015
• Date of Event: March 22, 2013
• Report Date: December 14, 2015
• Manufacturer: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
• Product Code: GCJ
• PMA / PMN Number: K061180
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: DC, US
• Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE. DEVICE NOT RETURNED FOR EVALUATION.

Description of Event or Problem · 1

ALLEGEDLY, THE PATIENT UNDERWENT A GYNECOLOGIC SURGERY TO REMOVE WHAT WERE THOUGHT TO BE BENIGN FIBROID TUMORS IN WHICH A MORCELLATOR WAS USED. SHORTLY AFTER THE PROCEDURE THE PATIENT WAS DIAGNOSED WITH LEIOMYOSARCOMA BASED ON PATHOLOGICAL ANALYSIS OF THE MORCELLATED TISSUES. SHE DIED ON (B)(6) 2013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
821961	UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM	MORCELLATOR	GCJ	KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY	26711101-1

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death

Terms

Patient problem · 2

• Cancer
• Death

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• OTHER