• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG RUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE RONGEURS/KERRISONS/IVDS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

S.U.A. MARTIN GMBH &CO.KG RUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE RONGEURS/KERRISONS/IVDS Back to Search Results
Catalog Number RN4853 / 130814
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2015
Event Type  malfunction  
Manufacturer Narrative
The two devices, manufactured respectively on 01/28/2015 and 05/22/2015, were returned and evaluated. No failure was detected, device performance conforms to specifications. Device history records complete and conforming to specifications. Routine final inspection of devices includes 100% testing of cutting function. Complaint not confirmed. Device not returned to manufacturer.
 
Event Description
The doctor was performing a microsurgical discectomy and was biting soft tissue with the device. Device does not cut. No harm done but the case took longer due to tearing of the tissue as opposed to cutting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRUGGLES MICRO KERRISON RONGEUR - THIN FOOTPLATE
Type of DeviceRONGEURS/KERRISONS/IVDS
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 Key5472567
MDR Text Key39423507
Report Number8010386-2016-00005
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberRN4853 / 130814
Device Lot Number100180-1501, 100180-1505
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-