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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 RB4893 / 0130814ABS
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 rb4893 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 NameRUGGLES STEALTH MICRO EJECTOR KERRISON RONGEUR
Type of DeviceRONGEUR
Manufacturer (Section D)
S.U.A. MARTIN GMBH &CO.KG
uhlandstrasse 17
rietheim-weilheim, 78604
GM 78604
MDR Report Key7442553
MDR Text Key106035069
Report Number8010386-2018-00003
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
0 Patients were 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
Device Catalogue NumberRB4893 / 0130814ABS
Device Lot Number100180-1706
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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