It was reported that during a mid-urethral sling procedure using an obtryx system - halo, when the trocar was retracted through the patient, the tip of the sling system, consisting of the association loop and blue dilator, detached from the plastic sleeve containing the mesh.The physician then pulled out the portion of the plastic sleeve that had been introduced into the patient.In addition, a small plastic component that connected the dilator and sleeve was found detached inside the patient and was retrieved from her tissue using a tool.Upon examination of the device outside the patient, it appeared that the blue dilator and plastic sheaths had not been properly sealed together during production.The other side of the sling system was then examined, and it appeared that side had the same problem.A photo of the device outside the patient was provided, showing both the delivery devices and the protective sleeves.One of the blue dilators was still attached to the introducer and was detached from the clear plastic sleeve.Another mesh was used to successfully complete the procedure, with extended operating time reported.No further patient complications were reported.
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