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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC V. MUELLER LEKSELL RONGEUR, MANUAL

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CAREFUSION 2200, INC V. MUELLER LEKSELL RONGEUR, MANUAL Back to Search Results
Model Number NL632
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2017
Event Type  malfunction  
Event Description
A screw backed out of the rongeur during use. Instrument removed from table.
 
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Brand NameV. MUELLER LEKSELL
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION 2200, INC
75 north fairway drive
vernon hills IL 60061
MDR Report Key6947880
MDR Text Key89291853
Report Number6947880
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 09/18/2017,09/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL632
Device Catalogue NumberNL632
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/18/2017
Event Location Hospital
Date Report to Manufacturer09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
Treatment
NO
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