Based on the information provided, isi has not determined the root causes for the alleged instrument issue or the operative complication experienced by the patient.If additional information is received a follow-up mdr will be submitted to the fda.No previous complaint was reported relating to this event.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2015.No related system errors were found to have occurred during the da vinci-assisted surgical procedure.The system logs reveal that the only two instruments used during the surgical procedure were a permanent cautery hook instrument (part 428090-13; lot s10141007-244) and a fenestrated bipolar forceps instrument (part 428093-13; lot m10141128-638).Isi has reviewed the site's complaint history and as of the date of this report, no complaints have been reported by the site to isi involving either instrument.This complaint is being reported due to the following conclusion: while undergoing a da vinci-assisted surgical procedure, the plaintiff's attorney claims that the patient sustained a bowel perforation as a result of arcing of electrical energy from a robotic instrument.However, at this time, the causes of the patient's alleged operative complication and the alleged instrument issue are unknown.
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As part of a legal dispute, intuitive surgical, inc.(isi) received information regarding a patient who underwent a da vinci-assisted bilateral salpingo-oophorectomy procedure on (b)(6) 2015.The plaintiff's attorney alleges that the patient's small bowel was perforated during the course of the surgical procedure.The plaintiff's attorney claims that the small bowel perforation occurred as a result of arcing electricity from a monopolar hook or bi-polar forceps instrument.Isi was not provided with the operative report or any of the patient's medical records.No further clinical information was provided.
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As part of a legal dispute, intuitive surgical, inc.(isi) received the following additional information regarding the reported event: the plaintiff's attorney provided the operative report for the da vinci-assisted bilateral salpingoophorectomy procedure performed on (b)(6) 2015.In addition to other patient medical records.No operative complications were noted in the operative report and the estimated blood loss from the surgical procedure was 25 cc.There was no indication within the operative report that a malfunction of a da vinci system, instrument, or accessory occurred.At the conclusion of the surgical procedure, the surgeon noted that the patient was awakened and taken to the recovery room in good condition.The patient's condition was noted as stable.During the robotic surgery, another surgeon was called into the operating room as one of the ovarian specimens had extruded itself from the specimen pouch and was no longer in the location of the pelvis.The surgeon was called in to find the ovary and remove it via exploratory laparoscopy.Post-operatively, the patient underwent the following procedures: (b)(6) 2015 - (b)(6) 2016 - multiple ct-scans of abdomen and pelvis (b)(6) 2015 - exploratory laparotomy, small bowel resection (b)(6) 2015 - exploratory laparotomy, wound vac application (b)(6) 2015 - colonoscopy (b)(6) 2015 - exploratory laparotomy with colonoscopy, colonic decompression, application of whittman patch (b)(6) 2015 - exploratory laparotomy, re-opening of recent laparotomy, partial colectomy, complex abdominal wall closure with biologic mesh placement, wound vac placement, colon resection (b)(6) 2015 - wound vac removal (b)(6) 2015 - abdominal wound cleansing and re-dressing on (b)(6) 2015, the patient was diagnosed with abdominal abscesses.On (b)(6) 2016, the patient was assessed for left upper quadrant pain, a fall, and trauma.The patient was hospitalized from (b)(6) 2016 to (b)(6) 2016 for complaints of continued abdominal pain.On (b)(6) 2016, the patient underwent an upper gi endoscopy procedure.The patient was hospitalized again from (b)(6) 2017 to (b)(6) 2017 for left upper quadrant pain, pancreatitis, nausea, and vomiting.Based on the additional and current information provided, this complaint will remain reportable due to the following conclusion: while undergoing a da vinci-assisted surgical procedure, the plaintiff's attorney claims that the patient sustained a bowel perforation as a result of arcing of electrical energy from a robotic instrument.However, at this time, the causes of the patient's alleged operative complication and the alleged instrument issue are still unknown.
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