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Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Rectal Anastomotic Leakage (4482)
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Event Date 06/21/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, the complainant, (b)(6), reported that on day 7, patient complained of fever and noted purulent discharge from the anus; additionally, patient presented with leukocytosis and elevated crp.This adverse event was anastomotic leakage as revealed by digital examination for which antibiotic treatment was administered (metronidazole-500 mg 3x daily and cefuroxime-1 g).Patient symptoms disappeared for a resolution date of (b)(6) 2022.This event did not occur within the united states.The event occurred in (b)(6) hospital in lithuania.It was reported that the causality to the senhance surgical system was possible.The event occurred on (b)(6) 2022, and asensus surgical was internally made aware on (b)(6) 2023.
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Manufacturer Narrative
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Based on the complaint details (b)(4) the patient experienced fever, leukocytosis, elevated crp, and noted purulent discharge from the anus.A digital exam revealed anastomotic leakage.Patient was administered antibiotic therapy (metronidazole-500 mg 3x daily; cefuroxime-1 g) and recovered for a (b)(4) 2022 date of resolution.This event did not occur within the united states.This event occurred at klaipeda university hospital in lithuania.The event occurred on (b)(4) 2022, and asensus surgical was internally made aware on 09-aug-2023.According to the investigation, further responses from surgeon interviews indicated that the anastomotic leakage event was not related to the senhance surgical system, but rather considered to be a normal surgical complication unrelated to the robot.Furthermore, no malfunction of the senhance system was reported and no failures were identified.The risk posed by this event was evaluated through a health hazard evaluation (hhe-001-00032) and a corrective action preventative action plan (capa-000048) has been opened to manage the unsuitable timeliness of the receipt and management of this reported event.Therefore, asensus surgical is reporting this followup for completeness to the initial mdr report submitted on 19-september-2023.
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Event Description
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On (b)(6) -2022, the complainant, (b)(6) reported that on day 7, patient complained of fever and noted purulent discharge from the anus; additionally, patient presented with leukocytosis and elevated crp.This adverse event was anastomotic leakage as revealed by digital examination for which antibiotic treatment was administered (metronidazole-500 mg 3x daily and cefuroxime-1 g).Patient symptoms dissapeared for a resolution date of (b)(6) 2022.This event did not occur within the united states.The event occurred in (b)(6).It was reported that the causality to the senhance surgical system was possible.The event occurred on (b)(6) 2022, and asensus surgical was internally made aware on 09-august-2023.
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Search Alerts/Recalls
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