OTSC SYSTEM SET

Additional Manufacturer Narrative

THE DEVICE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR TECHNICAL ANALYSIS. THE OTSC AND TWIN GRASPER WERE USED FOR HEMOSTASIS TREATMENT WHEN THE GRASPER WAS ACCIDENTALLY CLIPPED TO THE TISSUE. IT WAS REPORTED THAT BEFORE CLIP DEPLOYMENT THE GRASPER WAS PULLED BACK BUT THE VISABILITY WAS VERY LIMITED. IT IS STATED IN THE INSTRUCTIONS OF USE THAT THE GRASPING DEVICE MUST BE SUFFICIENTLY BE DRAWN BACK TO THE APPLICATION CAP WHILE THE CLIP IS RELEASED. OTHERWISE THERE IS A RISK THAT THE CLIP MAY BE APPLIED TO THE INSTRUMENT SHAFT OR THE BRANCHES AND THE INSTRUMENT MAY BECOME ATTACHED TO THE TISSUE AS A RESULT. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION.

Description of Event or Problem

THE OTSC WAS USED FOR THE TREATMENT OF A BLEEDING IN THE DUODENAL BULB. A TWIN GRASPER WAS USED FOR TISSUE MOBILIZATION. THE TISSUE WAS FIBROTIC AND THEREFORE DIFFICULT TO MOBILIZE INTO THE CAP. THE USER DID NOT REALIZE THAT THE GRASPING INSTRUMENT HAD NOT BEEN RETRACTED FAR ENOUGH INTO THE CAP. IN THE FOLLOWING THE TWIN GRASPER WAS ACCIDENTALLY CLIPPED TO THE TISSUE. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL THE FOLLOWING DAY TO HAVE THE GRASPING DEVICE REMOVED. IN THE MEANTIME, THE GRASPER HAD DETACHED ITSELF FROM THE CLIP AND COULD BE REMOVED WITHOUT ANY PROBLEMS. THE CLIP WAS STILL FIRMLY IN PLACE IN THE TISSUE AND HAD SEALED THE HAEMORRHAGE. NO FURTHER TREATMENT OF THE PATIENT WAS NECESSARY.

Additional Manufacturer Narrative

FOLLOW-UP REPORT: ADDITION OF RELATED REPORT NUMBER (0506030000-2025-8001) IN FIELD H10. NO FURTHER CONTENT CHANGE.