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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEHLING INSTRUMENTS GMBH & CO. KG CERAMO CONCEPT X PUNCH MANUAL RONGEUR

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FEHLING INSTRUMENTS GMBH & CO. KG CERAMO CONCEPT X PUNCH MANUAL RONGEUR Back to Search Results
Model Number TEB-2X
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2018
Event Type  malfunction  
Event Description
In a (b)(6) hospital, a part of a manual rongeur (punch) has broken off. The broken part was retrieved from the patient. The patient was not harmed.
 
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Brand NameCERAMO CONCEPT X PUNCH
Type of DeviceMANUAL RONGEUR
Manufacturer (Section D)
FEHLING INSTRUMENTS GMBH & CO. KG
hanauer landstr. 7a
karlstein, bavaria 63791
GM 63791
Manufacturer (Section G)
FEHLING INSTRUMENTS GMBH & CO. KG
hanauer landstr. 7a
karlstein, bavaria 63791
GM 63791
Manufacturer Contact
ulrike lindner
hanauer landstr. 7a
karlstein, bavaria 63791
GM   63791
MDR Report Key8110919
MDR Text Key128874976
Report Number9615005-2018-00002
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
K153243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Repair
Type of Report Initial
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTEB-2X
Device Catalogue NumberTEB-2X
Device Lot NumberX16L538CK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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