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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 STEREOTAXY

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INTEGRA LIFESCIENCES CORPORATION OH/USA CRW PRECISION ARC SYSTEM STEREOTAXY Back to Search Results
Catalog Number CRWPRECISE
Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation completed 11/16/2017. Device history record reviewed for product id crwprecise, serial # (b)(4) was manufactured on 08feb15 with no abnormalities related to the reported failure. The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework. There is no service history for this device. A two year look back from 11/02/2015 to 11/02/2017 for this reported failure and or related to "frame slipped" for product id's crwprecise shows no other prior complaints were received; no new design or manufacturing trends have been identified. One crwprecise crw precision arc system was received at the (b)(4) service centre in october-2017. The device was received without the lateral slide lock. Crw trunnions were found to lock as intended. The trunion components (shafts, knobs, and rings) were within specification. Resolution: the device is being shipped back to the customer, in same condition as it was received. The customer is advised to tighten both the thumb screws on the trunnions after tightening both the trunion rings. The reported failure mode was not duplicated, the complaint is unconfirmed.
 
Event Description
It was reported that the frame was not locking when tightened and slipping during the case. The territory manager is following up with the customer for patient related information. No patient injury has been reported in the information received so far. The device has been recently returned to the customer after annual calibration. This was the first case after calibration.
 
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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
rowena bunuan
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7032453
MDR Text Key249110390
Report Number3004608878-2017-00312
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 10/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCRWPRECISE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2015
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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