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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1MM

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S.U.A. MARTIN GMBH &CO.KG T-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1MM Back to Search Results
Catalog Number NL4252-81T / 2110814BT
Device Problems Fracture (1260); Dent in Material (2526)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2016
Event Type  Injury  
Manufacturer Narrative
Hardness of affected part was tested and conformed to specifications. Manufacturing records reviewed and found to be conforming. A marked dent in the material near the fracture line indicates the device was subject to excessive stress and wear either during the surgical procedure that led to the event, prior to the event (device five years old), or both. Since the broken-off tip was not returned, the cause for this incident cannot be determined conclusively.
 
Event Description
An acf was being performed with simultaneous suction. The tip of the instrument broke off, but was not retrieved as it went into the neptune suction device. A c-arm image was taken to verify that the broken tip was not in the patient. The patient did not suffer injury and the procedure was completed as planned.
 
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Brand NameT-COAT MICRO HDL KERRISON RONGEUR THIN 8IN 1MM
Type of DeviceKERRISON RONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
Manufacturer (Section G)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
Manufacturer Contact
markus pauli
uhlandstrasse 17
rietheim-weilheim, 78604
GM   78604
4619668540
MDR Report Key5793802
MDR Text Key49513284
Report Number8010386-2016-00007
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNL4252-81T / 2110814BT
Device Lot NumberKG24 XMEO 07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/14/2016 Patient Sequence Number: 1
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