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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG LEKSELL RONGEUR JAW 3X10MM OVERLGTH 9-3/4IN

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S.U.A. MARTIN GMBH &CO.KG LEKSELL RONGEUR JAW 3X10MM OVERLGTH 9-3/4IN Back to Search Results
Catalog Number 03233 / NL 632 1P
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
The instrument was not returned and the lot number is unknown. No investigation possible. Complaint cannot be confirmed. If the device is provided for evaluation and/or additional information becomes available, a follow-up report will be submitted. Complaint history from january 2014 to january 2018 was reviewed for this device. No previous occurrence of the reported problem was found.
 
Event Description
A screw backed out of the rongeur during use. Instrument removed from table. The screw fell into the wound and was visible to the surgeon at the time of the occurrence, so he removed it and gave the instrument to the scrub tech to be removed from the surgical field.
 
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Brand NameLEKSELL RONGEUR JAW 3X10MM OVERLGTH 9-3/4IN
Type of DeviceRONGEUR
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
MDR Report Key7185115
MDR Text Key97083228
Report Number8010386-2018-00001
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 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03233 / NL 632 1P
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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