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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUGGLES STEALTH MICRO EJECTOR KERRISON RONGEURS RONGEURS/KERRISONS/IVDS

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INTEGRA YORK, PA INC. RUGGLES STEALTH MICRO EJECTOR KERRISON RONGEURS RONGEURS/KERRISONS/IVDS Back to Search Results
Catalog Number RB4892E
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Investigation completed on 06feb2018. The dhr review had no applicable engineering change order/manufacturing change order history. There were two ruggles ronguers, returned used/processed showing wear, staining. The rongeurs were tested for dullness using carton 250 g/m2. Upon testing, both cut as designed. The complaint report cannot be confirmed, due to the instrument testing within defined specification. Linked to mfg report number: 2523190-2018-00025.
 
Event Description
This report is 1 of the 2 complaints. On the (b)(6), the customer reported that a rb4892e ruggles stealth micro ejector kerrison rongeurs stopped cutting within 3-4 months of usage. Additional information received on (b)(6) 2018 indicating that the patient was prepped for laminectomy and that there was a 30 min delay because they had to open a different product. There was no patient injury reported.
 
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Brand NameRUGGLES STEALTH MICRO EJECTOR KERRISON RONGEURS
Type of DeviceRONGEURS/KERRISONS/IVDS
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
Manufacturer (Section G)
INTEGRA YORK, PA INC.
589 davies drive
york PA 17402
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7278675
MDR Text Key100524071
Report Number2523190-2018-00024
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRB4892E
Device Lot Number100180-1703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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