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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER T-COAT KERRISON RONGEURS RONGEUR, MANUAL

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CAREFUSION 2200, INC V. MUELLER T-COAT KERRISON RONGEURS RONGEUR, MANUAL Back to Search Results
Model Number NL4251-82T
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2017
Event Type  malfunction  
Event Description
During surgery the tip of a gold #2 kerrison rongeur broke off during the procedure. Broken tip was retrieved intact by surgeon.
 
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Brand NameV. MUELLER T-COAT KERRISON RONGEURS
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION 2200, INC
1 becton dr
franklin lakes NJ 07417
MDR Report Key6398594
MDR Text Key69758103
Report Number6398594
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/28/2017,03/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL4251-82T
Device Catalogue NumberNL4251-82T
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/28/2017
Event Location Hospital
Date Report to Manufacturer02/28/2017
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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