|
Model Number ONB12STF |
Device Problems
Leak/Splash (1354); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/14/2024 |
Event Type
malfunction
|
Event Description
|
According to the reporter, during a laparoscopic gastric bypass, when the instruments are used to enter through the trocar, their seal were damaged and disengaged for all 3 device.There was also air or gas leaked from the seal for all device.Another device was used to resolve the issue.There was no patient injury.
|
|
Manufacturer Narrative
|
D10: concomitant product: onb12stf - onb12stf versaone opt 12 std trocar, lot# j3g1274y onb12stf - onb12stf versaone opt 12 std trocar, lot# j3g1274y.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.
|
|
Search Alerts/Recalls
|
|
|