Model Number AAS00161-12 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2015 |
Event Type
Injury
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Event Description
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The patient suffered a pneumothorax during a superdimension procedure.It is unknown if the patient was hospitalized or required treatment at time of event.If additional information pertinent to the incident is obtained a follow-up report will be submitted.
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Manufacturer Narrative
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(b)(4).A component of the superdimension system, case recordings, has been received and is under evaluation.When the evaluation is complete a follow-up report will be submitted.There were no anomalies identified during the internal review of the dhr of the system console.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If additional information is received a follow-up report will be submitted.
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Manufacturer Narrative
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(b)(4).A site service visit was completed and a component of the superdimension system, the location board (lb), was found to be cracked.The system was evaluated with the damaged lb and passed all accuracy and functional testing.The damaged lb was replaced and returned for further evaluation.Accuracy and functional testing of the system was performed with the new lb and met specification.Subsequent testing of the returned lb was performed at superdimension.Although visual damage to the lb was verified it did not affect the accuracy of the system, proven via three accuracy tests.A component of the superdimension system; case recordings, was returned and evaluated.The results showed the root cause to be an insufficient survey of the lungs by the user.If additional information pertinent to the incident is obtained another follow-up report will be submitted.
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Event Description
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The site reported they experienced difficulty completing registration of the patient's lungs.
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Search Alerts/Recalls
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