Statements in the instructions for use include: "twist and pull the safety cap gently to remove.Caution: inspect clip delivery housing closely, and circumferentially, to make sure that none of the clip's points extend beyond the distal rim/edge.If any clip points extend beyond distal rim/edge, carefully replace safety cap, do not use this product, contact your local product specialist or customer service representative, and use a different device for procedure.Do not remove the handle stay until endoscope with loaded padlock clip defect closure system is in position over defect and ready for deployment." the device subject of the reported event was returned to steris endoscopy for evaluation.Examination of the returned device found the clip to be slightly advanced on the housing with the points protruding, however the cause of the advanced position could not be determined.The device history record was reviewed and confirmed the device was manufactured to specification.A us endoscopy representative provided in-service training regarding use of the padlock defect closure device to the facility, including checking the position of the clip points prior to intubation.No additional issues have been reported.
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The user facility reported that during intubation of an endoscope with a padlock clip defect closure device attached, the user noted blood in the esophagus and withdrew the endoscope.Upon withdrawal of the device, the user noted the points of the clip were protruding past the deployment housing.No treatment was required for the abrasion and the procedure was completed with other hemostatic clips.
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