• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA YORK, PA INC. ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 3MM Back to Search Results
Catalog Number RB5883
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
 
Event Description
Customer initially reports screws fell out of 2 kerrisons. Doctors are complaining they are not sharp, they are not cutting, they are tearing. On (b)(6) 2016 no harm done. On 9/30/16 customer reports she has no specific information for an event except one of the screws did fall into a patient wound.
 
Manufacturer Narrative
10/17/16 integra investigation completed. Method: failure analysis, device 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. Device history evaluation - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. 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/correction history: 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6029641
MDR Text Key57440985
Report Number2523190-2016-00179
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,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRB5883
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 Received10/17/2016
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

-
-