|
Model Number 470360 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hematoma (1884)
|
Event Date 03/31/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Based on the current information provided, the root cause of the customer reported incident is determined to be use-error in relation to the use of a long obturator with a short cannula according.None of the products related to this incident has been returned to isi for failure analysis evaluation.If additional information is received, a follow-up mdr will be submitted.No image or video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.Moreover, the system would not have been docked at the time of the incident.This complaint is reported due to the following conclusion: during a da vinci-assisted single vessel small thoracotomy procedure, the surgeon accidentally "nicked" the patient's heart during the placement of an 8 mm standard cannula with a long optical 8 mm bladeless obturator.The injury resulted in a epicardial hematoma.It was confirmed that there was no medical intervention rendered to the patient.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.
|
|
Event Description
|
It was reported that during a da vinci-assisted single vessel small thoracotomy procedure, the surgeon accidentally "nicked" the patient's heart with the long optical 8 mm bladeless trocar during the placement of an 8 mm standard cannula.The injury resulted in a epicardial hematoma.Although the reported event states there was no medical intervention rendered to the patient, it is unclear how the hematoma was resolved.There was no allegation of a malfunction of an intuitive surgical, inc.(isi) device.Isi contacted the site's cardiothoracic nurse manager and the following additional information regarding the reported event was obtained: she stated that the surgeon had informed her that he used a long obturator with a short cannula at the start of the thoracotomy procedure since they were out of stock of short obturators.At the time of insertion, the obturator nicked the heart.As a result, there was a minor hematoma.The nurse manager stated that the surgeon had confirmed he had not rendered any medical intervention as the injury was superficial.Isi contacted the surgeon; however, the surgeon stated the following it was a "minor bruise to epicardium, did not interfere with the case, but could have caused problems.No adverse event to patient." there was no medical intervention rendered to the patient.The cause of the reported incident is because ¿there was no stock of the regular port and had to use a port we weren¿t used to using.No long-term complications.¿.
|
|
Search Alerts/Recalls
|
|
|