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Model Number 471205-17 |
Device Problems
Entrapment of Device (1212); Difficult to Open or Close (2921)
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Patient Problems
Hemorrhage/Bleeding (1888); Great Vessel Perforation (2152); Unspecified Tissue Injury (4559)
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Event Date 02/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information currently provided, the cause of the complications cannot be determined.Isi requested that the fbf instrument be returned; however, as of the date of this report, isi has not received the device for evaluation.A system error log review was conducted for the procedure on (b)(6) 2021.While there were messages related to energy activation being halted, along with multiple other messages including ¿emergency stop button was pressed by a user on ssc2¿ (surgeon side console 2), there were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.The fbf instrument (part# 471205-17, lot# n10200810-0101) in use had 11 of 14 uses remaining.The prograsp forceps instrument in use was (part# 470093-11 lot# n11200106-0146) and it had 2 of 10 uses remaining.An isi failure analysis engineer (fae) conducted a log review and findings were as follows: we do not have a log message for irk but we do require e-stop to be pressed prior to irk use.While there is a log entry indicating that the e-stop was pressed by the user, it could have also could have been pressed for a number of reasons.There were some erbe generator errors (25920 and 25913) indicating energy activation halted by external equipment but based on the event description, there were no reported issues with energy activation.The 25920 error indicates that bipolar energy delivery was halted by external equipment.The 25913 is an erbe error for reading instrument data.Logs also revealed that the instruments were taken out of following around 3pm, and there was a fault at 3:21:21.When matching the times to the event logs, the recorded fault is the estop button being pressed.The endoscope and mega suturecut needle driver instruments were removed 20 mins prior to the fault, and all arms were taken out of following.During the fault, the fenestrated bipolar forceps (fbf) and prograsp instruments were removed.After this event, all instruments were removed and the sterile adapter/cannula were removed.No images or video clips were provided for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted hysterectomy procedure, there was unanticipated bleeding.As a result, the case was converted to open surgery to control the bleeding.Additionally, during the conversion to open surgery and process of removing the robotic instruments, tissue was damaged.The tissue defect was repaired during the open surgery.The causes of the intra-operative bleeding and subsequent tissue damage during the conversion to open surgery are unknown.
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Event Description
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It was reported that during a da vinci-assisted hysterectomy procedure, while the surgeon was ¿likely harvesting lymph nodes,¿ the surgeon injured the patient¿s aorta by unknown means, allegedly due to surgeon technique, which caused an unspecified amount of initial bleeding.It was reported that the patient had ¿underlying heart disease and atherosclerosis.¿ the surgeon allegedly said that she ¿didn¿t expect diseased vasculature.¿ the patient harm that was reported was that the ¿patient had to be converted to open surgery.¿ on 26-feb-2021, intuitive surgical, inc.(isi) obtained the following additional information from the surgeon regarding the reported event: during a da vinci-assisted malignant hysterectomy procedure, there was a report of an adverse event when the surgeon was performing a left lymph node dissection during the last portion of the case.The surgeon was doing a trans-peritoneal approach and went above the inferior mesenteric artery (ima).Upon completing the dissection, the lymph nodes were removed.Upon removing the lymph nodes, the surgeon observed ¿spontaneous bleeding due to an avulsed ima just where the ima comes off of the aorta due to underlying atherosclerosis that was not previously known.¿ this resulted in unexpected bleeding for which the surgeon grasped and clamped the bleeding vessel with a fenestrated bipolar forceps (fbf) instrument and used a prograsp instrument for retraction.The surgeon was able to control bleeding at which point there had been one unit of blood lost but no blood transfusion was required.The procedure converted to open surgery and the surgeons were able to control bleeding ¿upstream¿ with a ¿cephalade vessel loop below the renal vessels and above site of ima bleed.¿ a vascular surgeon was also called in and had ¿placed two clamps on both common iliac vessels¿ and bleeding was controlled.The da vinci surgeon then removed the da vinci camera port but then lost control of both the fbf and prograsp instruments when doing so.The emergency stop button was pressed and the da vinci surgeon tried to use an instrument release kit (irk) as, ¿the console would not work at all to control the arms.¿ in an effort to remove the da vinci instruments, the vascular surgeon ¿put a forceps instrument between the jaws (of the fbf instrument) to try and open the jaws but, according to the da vinci surgeon, the instrument came out with the jaws closed and with tissue in the tips; 7mm in diameter of tissue removed within the jaws¿ with the fbf instrument and approximately ¿5mm in diameter of tissue removed within the jaws¿ from the prograsp instrument.During the open surgery, the vascular surgeon performed a ¿bovine aortic graft that was stitched over the defect and it was about 7mm by 16mm in length.¿ during the open surgery, ¿three units of ffp and four units of prbc¿ were administered through transfusion.The patient received another one unit of packed red blood cells 72 hours post-operatively.The open surgery completed and the ¿patient did well.¿ the patient was reported as recovering and doing well.
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Search Alerts/Recalls
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