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Device Problem
Insufficient Information (3190)
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Patient Problems
Vomiting (2144); Stenosis of the esophagus (4487); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/28/2022 |
Event Type
Injury
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Event Description
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The complainant, (b)(6), reported that a patient experienced narrow stenosis in the gastro-esophageal area and vomiting for which treatment with antiemetics was administrated (domperidone-50,00 mg total dosage); additionally, an ogd + dilatation was performed for a (b)(6) 2022 date of resolution.It was reported that causality to the senhance surgical system was possible.This event did not occur within the united states.The event occurred in (b)(6).Additionally, this event occurred on (b)(6) 2022, and asensus surgical was internally made aware on 29-june-2022.
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Manufacturer Narrative
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Based on the complaint details ((b)(4)), the patient experienced narrow stenosis in the gastro-esophageal area and associated vomiting for which patient was treated with antiemetics (domperidone; total dosage administrated: 50,00 mg) and performed an ogd (oesophagogastroduodenoscopy) with dilatation for (b)(6) 2022 date of resolution.This event did not occur within the united states.This event occurred at (b)(6) in germany.The event occurred on 28-may-2022, and asensus surgical was made aware on 29-june-2022.According to the investigation, further interview questions posed to the surgeon confirm that patient id (b)(6) belonged to a male patient with an inguinal hernia, without surgical problems.The corrected patient credentials for this particular event is a female patient with id (b)(6) and was found to already be handled in a separate (b)(4) for the serious adverse event associated with verified female patient id (b)(6).Therefore, as no serious adverse event occurred on the male patient id (b)(6), this complaint is deemed erroneous.Asensus surgical is reporting this followup with the corrected patient data to update the initial mdr report submitted on 19-september-2023.
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Event Description
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The complainant, bettina pfeiffer, reported that a patient experienced narrow stenosis in the gastro-esophageal area and and vomiting for which treatment with antiemetics was administrated (domperidone-50,00 mg total dosage); additionally, an ogd + dilatation was performed for (b)(6) 2022 date of resolution.It was reported that causality to the senhance surgical system was possible.This event did not occur within the united states.The event occurred in (b)(6) in germany.Additionally, this event occurred on 28-may-2022, and asensus surgical was internally made aware on 29-june-2022.
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Search Alerts/Recalls
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