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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. DIA DETACH KERRISON MEDIUM 40UP 8 RUGGLES-REDMOND

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INTEGRA YORK, PA INC. DIA DETACH KERRISON MEDIUM 40UP 8 RUGGLES-REDMOND Back to Search Results
Catalog Number RD4822DTM
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
On 9/21/16 integra investigation completed. Method: failure analysis, devise history evaluation results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer. The rongeurs were not returned for further evaluation. Devise history evaluation - nonconforming product report / nonconforming material report history: none variance authorization / deviation history: none engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. The rongeurs were not returned for further evaluation.
 
Event Description
Doctors are complaining that they are not sharp, they are not cutting, they are tearing.
 
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Brand NameDIA DETACH KERRISON MEDIUM 40UP 8
Type of DeviceRUGGLES-REDMOND
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 Key6028412
MDR Text Key57447650
Report Number2523190-2016-00171
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRD4822DTM
Device Lot NumberUNKNOWN
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 Received09/21/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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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