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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM-POOL STEREOTAXY Back to Search Results
Catalog Number CRWPRECISEP
Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2016
Event Type  malfunction  
Event Description
On (b)(6) 2016 the crwprecisep precision arc system (pool device) was experiencing tightness and stiffness of the right trunion during a case and the doctor had concerns that it might lock. The device was being used for a deep brain stimulation (dbs) surgery. The surgery was completed and there was no patient injury or delay in surgery due to the product problem. The age and gender of the patient is pending.
 
Manufacturer Narrative
Integra has completed their internal investigation on 01/09/2017. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: evaluation of device: attempt to adjust the right trunnion found it to be locked in place; able to adjust the left trunnion. Further investigation found the issue to be lack of maintenance. It was noted that the crwprecisep had not been in for service since (b)(6) 2015. Preventative maintenance should occur once per year. Device history record reviewed for this product id manufactured on 20-jan-2011 and show no abnormalities related to the reported failure. This device listed one nonconformance which was (b)(4) and was issued when the device was sent into be repaired, due to the calibration of the device was not within specification, this was corrected and accepted when the repair was completed. This complaint, trunnion knob sticking, is not associated with the previous repair, and the final inspection records indicate the device functioned within specification prior to the final release. A two year look back in (b)(6) for this reported failure and or related to "tightness-stiffness, sticking" for this product id shows that 14 complaints were received including this case, see below. Capa (b)(4) has been issued to further investigate this reported failure. Conclusion: the root cause for this failure was determined to be poor or improper maintenance of the device. Improper cleaning and maintenance may cause the unit to bind and potentially fail upon assembly and use.
 
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Brand NameCRW PRECISION ARC SYSTEM-POOL
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
bina patel
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6136918
MDR Text Key61459381
Report Number3004608878-2016-00331
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
Report Date 11/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCRWPRECISEP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2011
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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