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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 Physical Resistance (2578); Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2016
Event Type  malfunction  
Event Description
On (b)(6) 2016 the crwprecise precision arc system rhs silver trunnion became jammed after tightening and required force to loosen it. The ils sales specialist was informed by the user facility that they needed to unjam it several times during a deep brain stimulation (dbs) procedure and needed to apply force to do so as it continually happened. There was no patient injury as a result of the problem, however it was reported that the incident led to the procedure being delayed by an estimated 30 minutes. The sales specialist attended and reported that when the unit was in the central sterilizing service department the device was lubricated with medilube and seemed to release; however, once locked, it jammed again.
 
Manufacturer Narrative
Integra has completed their internal investigation on 12/20/2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: evaluation of device: confirmed customer statement that ¿the rhs trunnion becomes jammed after tightening. Once lubricated with medilube and re-tightened, the rhs trunnion still jams. ¿ it was observed that the unit was covered with black residue and was sticky. In addition, the residue was found absorbed in the foam set in yellow, device case. The type of ¿medilube¿ the customer used for lubricant is unknown. Note that the crw precision arc system should be cleaned prior to lubrication for proper function. Note that the user manual states that silicone lubricant should be used. Device history record reviewed for this product id manufactured on nov 30 2012 show no abnormalities related to the reported failure. This device passed all required inspection points with no associated mrr¿s, variances or rework. A two year look back in (b)(6) for this reported failure and or related to "trunnion ring is completely stuck-jammed" for this product id shows that 14 complaints were received including this case. Capa has been issued to further investigate this reported failure. Conclusion: no malfunction; user error - improper maintenance of crw precision arc system.
 
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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
bina patel
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6136921
MDR Text Key61507100
Report Number3004608878-2016-00332
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 NumberCRWPRECISE
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 Received12/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2012
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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