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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM RONGEUR, MANUAL

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CAREFUSION 2200, INC V. MUELLER LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM RONGEUR, MANUAL Back to Search Results
Model Number NL6146
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 01/27/2020
Event Type  malfunction  
Event Description
The jaws of the narrow pituitary, out of the neuro ronguer set 002, broke while operating inside the disc space. Per the scrub tech, the instrument was not damaged or bent prior to dr. Using it. Surgery was prolonged while trying to retrieve the broken piece of the instrument. The broken piece was successfully removed from the patient.
 
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Brand NameV. MUELLER LOVE-GRUENWALD PITUITARY FORCEPS 2X10MM
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION 2200, INC
5 sunnen dr
saint louis MO 63143
MDR Report Key9699244
MDR Text Key178786221
Report Number9699244
Device Sequence Number1
Product Code HAE
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 01/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL6146
Device Catalogue NumberNL6146
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2020
Event Location Hospital
Date Report to Manufacturer02/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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