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Based on the current information provided, the cause of the operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, no products are expected for return to intuitive surgical, inc.(isi) for evaluation.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the system and instrument logs for the procedure has been performed.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.Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: large suture cut needle driver, and site reviews have shown that no complaints were filed against the instrument.Advanced technical review: the logs were reviewed by an isi advanced failure analysis engineer (fae) and the following findings were obtained: sureform 60 stapler with pn 480460-09, lot l93210113-0258 fired 9 reloads (2 blue reloads, followed by 4 green reloads, followed by 3 blue reloads).All firings were completed per the logs with no pauses for compression.There were no incomplete clamps in the procedure.The vessel sealer extend was used for approximately 4 hours and 3 minutes.There were no errors recorded in the dsp logs.In the e-100 logs, there were 82 instances of the ¿high initial starting impedance¿ message, indicating the impedance of the tissue in the jaws was higher than the generator expected.This message does not indicate an instrument failure, and typically suggests the surgeon was sealing or applying energy multiple times over the same area.The images that were provided were reviewed by the isi clinical development engineer (cde) team and the following findings were obtained: in the first image, the staple lines looked intact.The staple line seen at the forefront had a couple of malformed staples at the corner of the tissue but no bleeding was observed.There was some pooling of blood seen but no indication as to the source and cause of bleeding.The second image shows that the stapler was being inserted into the bowel opening for anastomosis.A medical review was performed by an isi medical safety officer an the following was noted: based upon the information presented in the description of events, it is unclear if the da vinci system, instrumentation, and/or accessories caused or contributed to the patient¿s mortality.The known information are as follows: a (b)(6)-year-old male with a history of hypertension and pre-operative hgb of 11 underwent robotic assisted laparoscopic distal gastrectomy with a roux-en-y reconstruction.The estimated blood loss was 100 ml.Post-operatively, the patient¿s condition declined.The patient became hypotensive.The patient returned to the operating room for a re-exploration.Bleeding from a branch of the hepatic artery in a lymphatic bed was identified as the source of the bleed.It was estimated that 800 ml of total of blood was lost from the branch of the hepatic artery.The surgeon was able to control the bleeding.The patient required icu level care after the second (re-exploration) surgery until expiring.The patient received blood transfusions while in the icu.Repeat imaging via a ct scan was performed while the patient was in the icu.The ct scan demonstrated finding in the upper portion of the abdomen.The findings were thought to be either residual hematoma or fluid due to a leak.The results of the ct scan were not definitive.The patient¿s cause of death was listed as sepsis.The unknown information are as follows: the indication for the primary surgical procedure.The patient¿s preoperative nutritional status.The instrumentation and approach used during the primary surgical procedure.The method used to create the gastrojejunal anastomosis.The extent of the lymph node dissection during the primary surgical procedure.How the second (re-operative) procedure was performed.If surgical drain was placed after the second re-operative procedure.If any additional studies were performed after the ct scan, while the patient was in the icu, to determine the etiology of the ct scan finding.Distal gastrectomy with a roux-en-y reconstruction is a complicated procedure with high morbidity and mortality.According to the article, ¿to roux or not to roux: a comparison between roux-en-y and billroth ii reconstruction following partial gastrectomy for gastric cancer,¿ by t.B.Tran et al, gastric cancer.2016 jul;19(3):994-1001, the 90-day mortality rate for distal gastrectomy with a roux-en-y reconstruction is 5.1%.Morbidity and mortality are influenced by the degree of lymph node dissection.The information presented in the description of events does not provide enough clarity as to the cause of the patient¿s post-operative bleed.Furthermore, the information does not point to a specific cause of death.Although the surgeon attributes the cause of death to be related to the atn due to a blood transfusion reaction, one must consider that acute hemolytic transfusion reactions due to blood transfusion occur in 1:76,000 blood transfusion.It seems more likely that the patient had a leak at the gastrojejunal anastomosis causing the patient¿s ongoing hypotension and fevers contributed to the patient¿s mortality as opposed to atn due to an acute hemolytic transfusion reaction.Given the current information available to me, i am unable to determine if the da vinci system, instrumentation, and/or accessories caused or contributed to the patient¿s mortality.The case will be re-reviewed if additional information becomes available.This complaint is a reportable adverse event due to the following: after a da vinci-assisted distal gastrectomy procedure on (b)(6) 2021, the patient developed bleeding from a small branch of the hepatic artery and underwent a laparotomy to evacuate the hematoma as well as to ligate the bleeding vessel.The patient was admitted to the icu post take back surgery but passed away on (b)(6) 2021.The cause of death was determined to be sepsis from an unknown source.The patient had several blood transfusion reactions with hypotension and fever.The surgeon believes the cause of death was acute tubular necrosis (atn) from blood transfusion reaction.There is no allegation of a malfunction of the da vinci system, instrument or accessories.The system log review did not show any events that would suggest a product issue.The stapler and vessel sealer extend logs reviewed did not indicate an instrument failure.This event is considered a reportable adverse event as the patient underwent a re-operation to ligate a bleeding vascular structure, was admitted to the icu, transfused with blood and suffered a blood loss of 800 ml from evacuation of the hematoma.Although there was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, and no instruments were returned for evaluation, based on the information available, the cause of the patient's post-operative complication is unknown.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date (2020 reports) is blank because the product is not implantable.Information for the blank fields in initial reporter name and address is not available.Fields pma/510k (2020 reports), adverse event, recall (if recall number is given) (2020 reports), and correction/removal number (2020 reports) are not applicable.
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It was reported that after a da vinci-assisted distal gastrectomy procedure on (b)(6) 2021, the patient developed bleeding in the middle of the same night from the lymph node biopsy site and underwent a laparotomy procedure.The patient passed away on (b)(6) 2021.On 25-june-2021, intuitive surgical, inc.(isi) followed up with the isi clinical sales associate (csa), who spoke to the surgeon, and obtained the following information: there was no known allegation of a malfunction of the da vinci system, instrument or accessories.The initial procedure was completed uneventfully.There was no inadvertent injury to any vessel/structures and the instruments worked as expected.On 29-june-2021, isi followed up with the surgeon and obtained the following information: the patient had a roux-en-y anastomosis during the distal gastrectomy.The initial blood loss was less than 100 ml and the patient was on the usual medications.About 3-4 hours post-operatively, the patient was hypotensive and was brought back to the or.He was found to have bleeding from a lymph node vessel (small branch of the hepatic artery) in the resection bed.The hematoma was evacuated, and the vessel was ligated.The amount of blood loss was 800 ml from the evacuation of hematoma.After the procedure to treat the bleeding, the patient was admitted to the icu.On the ct scan done prior to the patient's death, there was a question of a leak, but upon review by the surgeon, it was determined to be a small residual hematoma.The images were reviewed with a second radiologist and it was questionable if there was a small leak or possible streak artifact or a residual hematoma.The cause of death on the death certificate/autopsy report/discharge summary was sepsis with an unclear source.The patient had several blood transfusion reactions with hypotension and fever.The surgeon believes the cause of death was acute tubular necrosis (atn) from blood transfusion reaction.No instruments are available for return to isi.The patient was in his 70's, male, hispanic and weight of (b)(6) kg.The patient had a ct scan showing no large mass or significant lymphadenopathy.Hemoglobin was 11 g pre-operatively and the patient was hypertensive.
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