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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XOMED MICROFRANCE MFG FORCEPS MCL19BIS RIGHT BOUCHAYER HEART; FORCEPS, ENT
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XOMED MICROFRANCE MFG FORCEPS MCL19BIS RIGHT BOUCHAYER HEART; FORCEPS, ENT Back to Search Results
Model Number MCL19BIS
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2014
Event Type  malfunction  
Event Description
It was reported the tip of the forceps is ¿broken off¿.It was confirmed with the facility that the tip was bent, not broken.There was no patient impact.Product analysis found that the mobile jaw is broken and a fragment is missing.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
FORCEPS MCL19BIS RIGHT BOUCHAYER HEART
Type of Device
FORCEPS, ENT
Manufacturer (Section D)
XOMED MICROFRANCE MFG
saint-aubin-le-monial
bourbon-l'archambault 3160
FR  3160
Manufacturer (Section G)
MEDTRONIC XOMED, INC.
6743 southpoint drive north
jacksonville FL 32216
Manufacturer Contact
michelle alford
6743 southpoint drive north
jacksonville, FL 32216
9043328197
MDR Report Key3782168
MDR Text Key20265761
Report Number9680837-2014-00037
Device Sequence Number1
Product Code KAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCL19BIS
Device Catalogue NumberMCL19BIS
Device Lot Number100403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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