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Catalog Number AS-IFS1 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pneumothorax (2012)
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Event Date 03/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The customer reported that the device, as-ifs1, airseal ifs, 110v, was being used during a robot assisted gastrectomy on (b)(6) 2022 when it was reported ¿pneumothorax was confirmed after robot assisted gastrectomy.A few days later the patient was in remission.¿ the report indicated that this was discovered during post-op.The procedure was completed with any delay.There was no report of device malfunction during this event.Further assessment questioning found that there was no report of medical intervention or hospitalization.The current status of the patient is listed as ¿remission after a few days¿.This report is being raised on the basis of injury due to the report of patient with pneumothorax.
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Manufacturer Narrative
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The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.A dhr review was not conducted as the device has been in the field more than 12 months.The service history of the device was reviewed, and no data was found for previous service history.A two-year review of complaint history revealed there has been a total of (b)(6) complaints, regarding (b)(6)devices, for this device family and failure mode.During this same time frame (b)(6) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(6).Per the instructions for use, the user is advised that higher insufflation pressures (> 15 mm hg) of carbon dioxide insufflation can increase the risk of hypercarbia, subcutaneous emphysema, pneumomediastinum, pneumothorax, pneumoscrotum and urinary retention.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The customer reported that the device, as-ifs1, airseal ifs, 110v, was being used during a robot assisted gastrectomy on (b)(6) 2022 when it was reported ¿pneumothorax was confirmed after robot assisted gastrectomy.A few days later the patient was in remission.¿.The report indicated that this was discovered during post-op.The procedure was completed without any delay.There was no report of device malfunction during this event.Further assessment questioning found that there was no report of medical intervention or hospitalization.The current status of the patient is listed as ¿remission after a few days¿.This report is being raised on the basis of injury due to the report of patient with pneumothorax.
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Search Alerts/Recalls
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