• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM STEREOTAXY

  • 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 LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM STEREOTAXY Back to Search Results
Catalog Number CRWPRECISE
Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Integra has completed their internal investigation on (b)(6) 2017. Lot/serial number was not provided; should the product be returned a dhr review will be completed. A two year look back from (b)(6) 2015 to (b)(6) 2017 "trunion rings are sticking or is completely stuck " for product id crw precise shows that 22 complaints were received including this case. Root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation and it was reported that the issue was resolved by the customer. The reported complaint is considered unconfirmed.
 
Manufacturer Narrative
A review of our device history records for the reported serial number (b)(4), lot number 129 indicated the device was manufactured and released to specification. This product is inspected at 100% per inspection requirements prior to leaving integra facility. No service history is on file for this device.
 
Event Description
The crwprecise frame was opened in the operating room (theatre) for a deep brain stimulation (dbs) surgery and it came packed in an incorrect position and seemed jammed to begin with in the locked position. The trunnions where subsequently unable to be opened. The surgery was still in progress when the complaint information came through. The patient was prepped for dbs case when an issue with the arc was found. Patient age and gender unknown. The crw arc was not set up on the patient as it could not be unlocked. There was a delay to surgery while another device was found; delay of approximately 1 hour. Surgery continued with crwasl borrowed from a nearby facility. Additional information 11aug2017: the territory manager was able to speak to the hospital contact and confirmed that the trunnions were indeed locked at the central sterile supply department (cssd) level prior to steam autoclaving and they have since resolved the tightness and locking of the trunnion mechanism in cssd. The trunnions of the crw have been unlocked and the product will not be returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCRW PRECISION ARC SYSTEM
Type of DeviceSTEREOTAXY
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
cincinnati OH 45227
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6810851
MDR Text Key246429100
Report Number3004608878-2017-00255
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K944463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCRWPRECISE
Device Lot Number129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-