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Model Number 380652-41 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Death (1802); Blood Loss (2597)
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Event Date 08/09/2019 |
Event Type
Death
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Manufacturer Narrative
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Isi has attempted to gather additional information.However, no additional information was available as of the date of this report.If additional information is received, a follow-up mdr will be submitted.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure.On 08/12/2019, an isi field service engineer (fse) performed a system verification at the site and concluded the system met all specifications and was released for use.Device evaluation (failure analysis, product complaint history) was not possible, since the product was not returned and additional information (lot, serial number, etc.) could not be obtained for the trocar.No review of system or product information via system logs was possible for the event since the system was never used.No image or video clip for the reported event was submitted for review.The instructions for use (ifu) for the da vinci xi systems (pn - 553873-02) contains the following cautions to minimize the risks associated with port placement.Appropriate patient positioning to shift organs away from the port placement site.An adequate level of insufflation.Obturator tip is pointing away from major vessels, organs, and other anatomic structures.When possible, visualization of the entire insertion of the cannula using the endoscope is preferred.Utilize continuous, controlled pressure with a deliberate rotating motion when placing the cannula and obturator.Although there was no allegation of a malfunction of the isi trocar that was associated with this event, this event is being reported based on the following conclusion: the surgeon was performing initial entry in the abdominal cavity and the surgeon speculated that the liver was injured.The patient experienced intra-abdominal hemorrhage and as a result, the patient experienced a cardiac arrest that ultimately resulted in the patient¿s death.Since the product was not available for further evaluation, isi was unable to confirm if the device had contributed to the event.This report has been generated in response to fda inspectional observations dated 06-mar-2020.
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Event Description
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It was initially reported that prior to starting a planned da vinci-assisted inguinal hernia repair procedure, the patient expired.At that time, the da vinci surgical system was not docked to the patient, and the death was unrelated to the dv surgical system.On 09-aug-2019, intuitive surgical, inc.(isi) technical support engineer (tse) was contacted by the site¿s charge nurse and it was reported that the surgeon ¿had hit something but not with the robot.¿ another nurse at the site had informed the isi field service engineer (fse) that the davinci system was not docked when the patient expired.There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred or caused/contributed to the patient's demise.On 18-mar-2020, isi contacted the isi clinical sales representative (csr) and obtained the operative notes.It was reported that on (b)(6) 2019, a (b)(6) year old male was scheduled to undergo a da vinci-assisted inguinal hernia repair surgical procedure.An 8mm incision was placed and an 8mm trocar was inserted through the abdominal wall using the optiview technique.The fascia was somewhat resistant but the trocar was able to be advanced.The scope was then passed and it was observed that the trocar was in the preperitoneal space.The 8mm trocar was removed and a 5mm trocar was inserted using the optiview technique, which appeared to be in the abdominal space.The abdomen was insufflated, the camera was passed, and blood was present.At this point the anesthesiologist noted the patient was in asystole and chest compressions were immediately initiated.The 5mm trocar was removed, the incision was extended, and bleeding with dark blood was observed.A midline exploratory incision was made and it was observed that the patient had large amounts of blood in the right side of the abdomen.The abdomen was immediately packed and no additional bleeding was observed.Cpr continued and transfusion protocol was initiated.The site of the bleeding was not identified.Cardiac rhythm was never re-established and a code was called.On 16-april-2020, the csr obtained additional clarification from the surgeon regarding the operative notes and provided the following information: the initial 8mm trocar inserted was an isi trocar.Although the exact site of bleeding was unidentified, the surgeon speculates it was from the liver.The surgeon also stated that both the 8mm isi trocar and the 5mm non-isi trocar placement could have potentially caused the injury; however, the surgeon confirmed no allegation of malfunction of the da vinci surgical system, instrument or accessory.
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Search Alerts/Recalls
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