• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER STRYKER NEPTUNE 2 ULTRA WASTE MANAGEMENT DEVICE 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
 

STRYKER STRYKER NEPTUNE 2 ULTRA WASTE MANAGEMENT DEVICE SYSTEM Back to Search Results
Lot Number 1106101163
Device Problems Misconnection (1399); Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Exsanguination (1841)
Event Date 11/07/2012
Event Type  Death  
Event Description

The pt underwent a thoracotomy procedure. The chest tube was inadvertently attached to the stryker neptune 2 ultra instead of the pleurovac system causing massive bleeding and the pt expired. Reason for use: right lung mass s/p thoracotomy.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRYKER NEPTUNE 2 ULTRA WASTE MANAGEMENT DEVICE SYSTEM
Type of DeviceNEPTUNE
Manufacturer (Section D)
STRYKER
4100 e. milham ave
kalamazoo MI 49001
MDR Report Key2837516
MDR Text Key20981671
Report NumberMW5027653
Device Sequence Number1
Product Code FYD
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number1106101163
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 11/13/2012 Patient Sequence Number: 1
-
-