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

MAUDE Adverse Event Report: V. MUELLER / CAREFUSION 2200, INC. V.MUELLER STRAIGHT PITUITARY RONGEURS RONGEUR, MANUAL

  • 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
 

V. MUELLER / CAREFUSION 2200, INC. V.MUELLER STRAIGHT PITUITARY RONGEURS RONGEUR, MANUAL Back to Search Results
Model Number NL6147
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/27/2021
Event Type  malfunction  
Event Description
The up-bite of a straight pituitary rongeur broke off during a lumbar microdiscectomy. Unable to be retrieved by surgeon. Decision made to leave in to prevent more harm by trying to retrieve the piece. Disclosure given. Instrument was checked in spd and by the surgical tech, no defects noted. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameV.MUELLER STRAIGHT PITUITARY RONGEURS
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
V. MUELLER / CAREFUSION 2200, INC.
MDR Report Key12728508
MDR Text Key279827023
Report NumberMW5105048
Device Sequence Number1
Product Code HAE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL6147
Device Catalogue NumberNL6147
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
-
-