Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KARL STORZ SE & CO. KG UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM Back to Search Results
Model Number 26711101-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cancer (3262)
Event Date 01/13/2012
Event Type  Death  
Manufacturer Narrative
There was no indication of any malfunction of the device.
 
Event Description
Allegedly, the patient underwent a supracervical laparoscopic hysterectomy procedure on (b)(6) 2012 in which a morcellator was used.The patient subsequently developed leiyomyosarcoma and later passed away on (b)(6) 2016.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM
Type of Device
MORCELLATOR
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM  
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key7780709
MDR Text Key117037932
Report Number9610617-2018-00055
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2018
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model Number26711101-1
Device Catalogue Number26711101-1
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age52 YR
-
-