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Model Number 380652-49 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Urinary Retention (2119); Pericardial Effusion (3271); Unspecified Blood or Lymphatic problem (4434)
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Event Type
Injury
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Event Description
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On 10-jan-2022, intuitive surgical, inc.(isi) became aware of a journal of clinical medicine article titled, ¿robotic vs.Transsternal thymectomy: a single-center experience over 10 years¿ (kocher, g.J., et.Al.2021).Within the journal article, operative complications were noted.In the robotic group, five patients had a post-operative complication that included chylothorax, pericardial effusion, and urinary retention.The resection of surrounding structures was performed for five patients in the robotic assisted thoracic surgery (rats) group and seven patients in the transternal (ts) group.It was further noted: "after a mean follow-up of 44 months (range 1-108), n = 4 patients with thymoma showed recurrence, 3 were treated via a transsternal approach, and only 1 was treated via a rats approach.In the group with thymic carcinoma, 1 patient showed pleural recurrence after 14 months and was treated through a minimally invasive resection of the recurrence sites.Five patients died during follow-up; only one of these deaths was due to tumor progression." isi has reached out to the author to obtain additional information but has not yet received a response.
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Manufacturer Narrative
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Based on the current information provided, the root cause of post-operative complications associated with rats cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history shows no other complaints related to the complications reported in this event.No image or video clip for the reported event was submitted for review.No product is expected to be returned for analysis.A review of the system and instrument logs was not possible as there are currently three known da vinci xi systems present at the procedure site: (b)(4) and the procedure dates associated with the post-operative complications are unknown.Log review is not possible due to a lack of system and instrument details, event/procedure dates, and confirmation of site location.This complaint is being reported due to the following: within the journal of clinical medicine article titled, ¿robotic vs.Transsternal thymectomy: a single-center experience over 10 years,¿ a number of postoperative complications 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 are unknown.Refer to the fda medwatch report with patient identifier (b)(6) for additional information regarding the 5 patient deaths that occurred during follow-up noted within the article.
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Search Alerts/Recalls
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