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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Liver Damage/Dysfunction (1954); Sepsis (2067)
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Event Type
Death
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Event Description
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On 11-oct-2021, intuitive surgical inc, (isi) became aware of a jtcvs techniques article titled, ¿robotics-assisted epicardial left atrial appendage clip exclusion" (antaki,t., michaelman, j., et al., 2021).Within the journal article, the following post- operative complications were noted: one case of hemothorax requiring thoracoscopy, one case of late lacunar stroke 18 months post-operatively due to in situ small intracranial vessel thrombosis, 4 out of 42 patient had severe hyponatremia with sodium level <125 meq/l causing added length stay, two patients experienced late gastrointestinal bleeding, despite being off oral anticoagulant (oacs), one patient with a cha2ds2-vasc score of 9 remained on apixaban per her other health care provider¿s judgment, 5 patient had urinary retention, 2 patients had acute chronic renal insufficiency, 1 patient had pneumonia.Additionally, 2 patient deaths were reported at 6 and 11 months respectively due to abdominal sepsis, 1 death was reported at 12 months due to pancreatic cancer, and 1 death at 2 months due to liver failure.Isi has reached out to the author to obtain additional information but has not received any additional information as of the date of this report.
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Manufacturer Narrative
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Based on the current information provided, the root causes of the reported post-operative complications resulting with deaths cannot be determined or is unknown.Isi has attempted to contact the author to gather additional information regarding the patients/incidents.However, as of the date of this report, no additional information has been obtained.If additional information is received, a follow-up mdr will be submitted.A review of the system and instrument logs was not possible as there are currently two known xi systems present at the procedure site: sk1280 and sk 3691.Further log review is not possible due to lack of system and instrument detail, event/procedure date, and confirmation of site location.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following: within the tcvs techniques article titled, ¿robotics-assisted epicardial left atrial appendage clip exclusion," a number of patient deaths were noted.Although there is no allegation within the article that a malfunction of an isi system, instrument, or accessory occurred, the causes of the post-operative complications resulting with patient deaths are unknown.Refer to fda medwatch report with patient identifier # (b)(6) for additional information regarding the non-death related complications noted within the article.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The date of death is unknown.The actual date of the event is unknown.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.Insufficient product information was provided in order to obtain the 510k number.Insufficient product information was provided in order to obtain the date of manufacture.
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Search Alerts/Recalls
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