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Model Number NONB12STF |
Device Problems
Leak/Splash (1354); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during the laparoscopic roux en y gastric bypass, about halfway through the procedure, the surgeon's left hand 12mm.Port began to audibly leak co2 while an instrument was inserted into the port.The leak started after multiple instrument exchanges from 5mm to 12mm shafted devices.The co2 leak was exacerbated when torque was put on the port site, but still present without torque.It was noted that the seal disengaged for both trocars, for the 12mm it was the upper disc valve and for the 5mm it was the lower valve.Shortly the 5mm assist port began to leak when there was no instrument placed inside the trocar which was likely caused by debris being lodge in the value. it was identified that the route of the problem was the disk valve, so the trocar cap was replaced by a new 12mm trocar cap, and the leak ceased.No device component fell into the cavity of the patient.There was no patient injury.
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Manufacturer Narrative
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D10 concomitant products: nonb5stf, nonb5stf no blade 5mm std fix (lot#:j3m2728y).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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