Model Number 909077A |
Device Problems
Failure to Cut (2587); Device Operates Differently Than Expected (2913)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint was returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).
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Event Description
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Per dr.(b)(6) unit has been used 3 times since purchase in 2014 and malfunction occurred with each use.On 2 occasions the unit cut but would not coag and "excessive bleeding" occurred.On the 3rd occasion the unit would not cut or coag.(b)(4).
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Manufacturer Narrative
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(b)(4).Investigation: inspect returned samples: initiated manufacturer's investigation.No sample returned.Review dhr: inspect stock product.Analysis and findings: a review of the 2 yr complaint history reveals similar issues.A review of the dhr reveals no anomalies.The unit was received damaged.The customer had not packed the item correctly resulting in damage to the integration unit components.The unit was not sent back with the appropriate paperwork nor was csi notified of the return.The customer refused an in service and returned the unit instead.The integration unit as a whole was checked out for power output and function and found to operate to specifications.The root cause is not definitively determined but given the units' function was found to be normal and free of defects it is likely user error can account for this complaint condition.Correction and/or corrective action: all components were scrapped except the generator, p/n 909075.It will be run through its own tests to double check for any additional information.Unit will either be re-stocked as a demo or scrapped.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Corrective action level 4: train personnel.Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? yes.Review and closure: recommended continuous improvement program (cip).Preventative action activity: reviewed.Trend and monitor to cip.
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Event Description
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Per dr.(b)(6) unit has been used 3 times since purchase in 2014 and malfunction occurred with each use.On 2 occasions the unit cut but would not coag and "excessive bleeding" occurred.On the 3rd occasion the unit would not cut or coag.(b)(4).
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Search Alerts/Recalls
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