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: CAREFUSION 2200, INC SNOWDEN-PENCER; LAPAROSCOPE, GENERAL PLASTIC SURGERY
  • 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
 

CAREFUSION 2200, INC SNOWDEN-PENCER; LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number TSR5105
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2018
Event Type  malfunction  
Event Description
A tsr5105 trocar cannula sealed junction came apart.This trocar should not come apart at this junction.Once the trocar came apart, bio burden was exposed that had been collecting in the gap.This small gap between the metallic portion and the black threaded cannula portion is susceptible to the collection of bio burden and could theoretically expose patients to risk.Manufacturer response for trocar cannula, trocar cannula, radel threaded (per site reporter): this issue was reported to (b)(4).We will receive a failure analysis report when they conclude their investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SNOWDEN-PENCER
Type of Device
LAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
CAREFUSION 2200, INC
75 north fairway drive
vernon hills IL 60061
MDR Report Key8276861
MDR Text Key134072610
Report Number8276861
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberTSR5105
Device Catalogue NumberTSR5105
Device Lot Number118592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2019
Event Location Hospital
Date Report to Manufacturer01/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-