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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 3MM

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INTEGRA YORK, PA INC. ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 3MM Back to Search Results
Catalog Number RB5883
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Investigation completed 09/01/2017. Dhr review: nonconforming product report / nonconforming material report history: none a two year look back found 1 complaint for this product id, and that 1 reported had a failure related to "screw falling out". Failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation after several documented attempts. Root cause cannot be determined due to the lack of information received to perform a complete investigation.
 
Event Description
A screw from a kerrison rongeur fell into a patient and had to be removed with a magnet. No harm to patient.
 
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Brand NameULTRA-COAT MICRO EJECT KERRISON 40D UP 8 3MM
Type of DeviceULTRA-COAT
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
sandra lee
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6856318
MDR Text Key86009723
Report Number2523190-2017-00089
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
K153243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRB5883
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 Received08/15/2017
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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