The device subject of this complaint was returned to steris endoscopy for evaluation.Evaluation of the returned device found the linking cable was kinked and buckled, indicative of overly aggressive bending of the cable, and of excessive force applied upon deployment.The observed damage would cause the deployment issue described.Statements from the instructions for use include: "check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that the housing isn't expanded.Too tight of a fit can expand the scope mounting feature making the pushing mechanism sluggish and allow the padlock clip to get hung up on deployment, especially in retroflexion.Avoid bending the linking cable too aggressively or using a grasping/clamping device on the linking cable as it can create a "kink" and/or disable device function.Deploy padlock clip by using a firm and rapid thrust of the thumb actuator while holding the control handle body." the device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Steris endoscopy has offered in-service training to the user facility; however, the user facility has not responded.No further issues have been reported.
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The user facility reported incomplete deployment of a padlock clip defect closure device during a patient procedure, and the user utilized forceps to assist deployment.The clip was deployed successfully, the procedure was completed, and no harm to the patient or user was reported.
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