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Model Number 470172-16 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Injury (2348)
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Event Date 09/15/2020 |
Event Type
Death
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Manufacturer Narrative
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Based on the current information provided, the cause of the alleged intra-operative complication cannot be determined.According to the anesthesiologist, the intestinal injury might have been related to grasping the intestinal tract with a maryland bipolar forceps instrument.However, the anesthesiologist claimed that the instrument did not malfunction and is not available for return to isi for failure analysis investigation.A follow-up mdr will be submitted if additional information is received about the event.A review of the system and instrument logs 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.The instrument logs reveal that the endoscope used during the case has been used in subsequent procedures and site reviews have shown that no complaints were filed against the endoscope.The following instruments used during the case have not been used in subsequent cases: maryland bipolar forceps (part #470172-16; lot #n12200330-0157) suction irrigator (part #480299-06; lot #m10191029-0266) is a single-use instrument and site reviews have shown that no complaints were filed against the instrument.Fenestrated bipolar forceps (part #470205-17; lot #n11200102-0085) and site reviews have shown that no complaints were filed against the instrument.Fenestrated bipolar forceps (part #470205-17; lot #n13200113-0421) and site reviews have shown that an unrelated complaint was reported for this instrument.It was alleged that the instrument could not be removed during the same procedure after the instrument was used.An inspection of the instrument intra-operatively with a camera revealed that the instruments wrist was dislodged from the shaft.The instrument was successfully removed with the cannula still attached.As of the date of this report, isi has received the instrument for failure analysis investigation; however, the evaluation of the instrument has not been completed.The anesthesiologist explained that the rectal injury sustained by the patient was unrelated to the alleged issue with the fenestrated bipolar forceps instrument.This complaint is being reported due to the following conclusion: after completion of a da vinci-assisted hysterectomy procedure, a rectal injury was identified and repaired with sutures.Although the anesthesiologist claimed that the rectal injury might have been caused by grasping the intestinal tract with a maryland bipolar forceps instrument, the anesthesiologist indicated that the instrument did not malfunction.At this time, the cause of the rectal injury is unknown.The product is not implantable.
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Event Description
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It was initially reported that after completion of a da vinci-assisted total benign hysterectomy procedure, the patients rectum was found to be perforated.In addition, intestinal necrosis had occurred and the patient was reportedly in serious condition.On 28-sep-2020, intuitive surgical, inc.(isi) received information indicating that the case was completed robotically; it was not converted to traditional laparoscopic surgery or open surgery.In addition, the patient was under intensive care.On 06-oct-2020, isi obtained the following additional information regarding the reported event from an anesthesiologist: as of 06-oct-2020, it was not possible to obtain additional information from the surgeon regarding the reported event.Per the anesthesiologist, a review of the surgical procedure on video determined that the rectal injury may have been related to grasping the intestinal tract with a maryland bipolar forceps instrument.There was no malfunction of the maryland bipolar forceps instrument.Therefore, the instrument will not be sent back to isi for evaluation.The anesthesiologist indicated that part of the injury was repaired with sutures using the da vinci surgical system.Also, during the case, a fenestrated bipolar forceps (part #470205-17; lot #n13200113-0421) allegedly got stuck and could not be removed after use.The surgical staff was able to remove the instrument with the cannula still attached.The anesthesiologist explained that the rectal injury was unrelated to the alleged issue with the fenestrated bipolar forceps instrument.It was noted that the patient was alive but his/her current status was unknown.
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Manufacturer Narrative
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On 30-nov-2020, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event from the site¿s anesthesiology department and a medical examiner: the patient reportedly expired on (b)(6) 2020 ¿due to poor progress of emergency surgery for rectal perforation and intestinal necrosis.¿ it was noted that ¿after video verification in the hospital, the cause of the intestinal injury was thought to be the grasping of the intestinal tract by the da vinci¿s maryland bipolar.¿ furthermore, it was noted: ¿there was no maryland failure during procedure.¿ the surgeon is not available to be interviewed regarding the reported event.On 22-dec-2020 an isi internal medical safety officer provided the following after reviewing the case information: "according to the description of events, the patient underwent a da vinci assisted hysterectomy procedure and sustained an injury to the rectum, which the site believes was due to the use of the maryland bipolar forceps.The rectal injury was repaired using sutures.The patient's post-operative course was complicated by intestinal necrosis and rectal perforation which ultimately led to the patient¿s death.The depth, exact location and extend of the rectal injury are not indicated in the information above.It is also unclear as to who performed the repair of the rectal injury.Moreover, the cause of the intestinal necrosis cannot be determined from the information above.Ideally, additional information would be beneficial, such as patient¿s past medical history and any associated underlying co-morbid conditions that might indicate vascular compromise, such as peripheral vascular disease, cardiac condition¿s such as atrial fibrillation or congestive heart failure, smoking status, and previous surgical history.Certainly, a surgeon¿s technique and tissue handling may to create an inadvertent bowel through the use of proper functioning instrumentation either laparoscopically or robotically.The risk of inadvertent bowel injury increases in the presence of adhesions.In the above case, there are not reported issues with the maryland bipolar forceps.The site indicates the injury occurred to the rectum due to the surgeon grasping the rectum with the maryland bipolar forceps.The injury to the rectum is most likely related to the surgeon's technique and tissue handling.As this case was a da vinci assisted hysterectomy, it is unclear how the da vinci system, instrumentation, and accessories could have caused or contributed to the intestinal necrosis given that there are no reported issues from the procedure related to the small bowel.The patient¿s underlying health conditions most likely caused the intestinal necrosis.".
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Search Alerts/Recalls
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