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Model Number ONB12STF |
Device Problems
Leak/Splash (1354); Decrease in Pressure (1490); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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According to the reporter, during a laparoscopic rectosigmoidectomy procedure, when the material was opened, the puncture was performed in the patient following the manufacturer's guidelines, and when passing the clip even carefully and slowly, the valve ruptured, thus causing a large loss of pneumoperitoneum and rapid loss of abdominal pressure.It was noted that air or gas leaked from the seal.There was no patient injury.
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Search Alerts/Recalls
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