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Model Number ONB11STF |
Device Problems
Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Emphysema (1832); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/28/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during laparoscopic hysterectomy, insufflation of the abdominal cavity, there was a leak of gas at the pr oximal part of the two cannulas close to the valve.It was reported that the patient acquired subcutaneous emphysema.Pressure was applied on the abdominal wall to remove gas (co2) trapped in subcutaneous tissue.
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Manufacturer Narrative
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D10 concomitant product: onb11stf versaone opt 11mm std trocar (lot#: j3k4747y) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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