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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG RUGGLES STEALTH MICRO EJECTOR KERRISON RONGEUR
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S.U.A. MARTIN GMBH &CO.KG RUGGLES STEALTH MICRO EJECTOR KERRISON RONGEUR Back to Search Results
Catalog Number RB4892E / 0120814ABS
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Manufacturing records, including quality inspection documents, were reviewed and found to be conforming.No investigation possible since the device has not been returned.If additional information becomes available, a follow-up report will be submitted.
 
Event Description
The second week of (b)(6), the customer reported that an rb4892e ruggles stealth micro ejector kerrison rongeur stopped cutting within 3-4 months of usage.Additional information received on 01/01/2018 and 02/14/2018 indicated that the patient had been prepped for laminectomy.There was a 30-minute delay because a different product had to be opened.There was no patient injury.
 
Manufacturer Narrative
As per the specification developer, the device was returned by the user to the specification developer, who tested it for cutting performance.The device conformed to defined specifications and was resent to the user.Complaint cannot be confirmed.
 
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Brand Name
RUGGLES STEALTH MICRO EJECTOR KERRISON RONGEUR
Type of Device
RONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM  78604
MDR Report Key7442546
MDR Text Key106266891
Report Number8010386-2018-00002
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
K150428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRB4892E / 0120814ABS
Device Lot Number100180-1703
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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