DIAGNOSTIC FTRD SET
Received Aug 23, 2022 · Event occurred Jul 29, 2022
Report 15275043 · MDR key 15275043
Device
Generic name
Endoscopic Grasping/cutting Instrument, Non-powered
Manufacturer
Ovesco Endoscopy AgModel number
13Catalog number
200.76
Lot number
826006
Product problems
- Activation Problem
Patient
21900 DA · Female
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
THE COLONOSCOPY WAS COMPLETED AND POLYP AT APPENDICEAL ORIFICE WAS NOTED. THE SCOPE WAS WITHDRAWN AND THE TEAM SET UP FOR FTRD WITH OTSC (CLIP). ONCE SET UP, THE SCOPE WAS DEPLOYED, THE AREA FOR RESECTION WAS MARKED AND THE FTRD GRASPER WAS DEPLOYED. THE TISSUE WAS GRASPED AND PULLED INTO THE CAP OF THE FTRD. THE PHYSICIAN STATED THAT ONCE THE TISSUE WAS PULLED IN, SHE DEPLOYED THE CLIP AND THE SNARE. SHE STATED SHE COULD NOT SEE MUCH DUE TO TISSUE OBSTRUCTING HER VIEW. ONCE THE CLIP WAS THOUGHT TO BE DEPLOYED AND THE HOT SNARE ACTIVATED WITH TISSUE CUT, SCOPE WAS WITHDRAWN AND THE TIP IS NOTED TO HAVE BLOOD ON IT WITH THE CLIP STILL ATTACHED, THE SCOPE WAS RE-INSERTED AND THE SITE OF THE FTRD INSPECTED AND FOUND TO BE BLEEDING. 9 ENDOCLIPS WERE DEPLOYED AND THE BLEEDING APPEARED TO BE CONTROLLED. THE OVESCO CLIP DID NOT DEPLOY AFTER TURNING THE MECHANISM THAT IS DESIGNED TO DEPLOY THE CLIP. THE INTRA-PROCEDURE TEAM THOUGHT THE CLIP HAD BEEN DEPLOYED AND THE TISSUE THAT WAS INVOLVED WAS HOT SNARED. AFTER SNARING, THE OVESCO CLIP WAS VISUALIZED BY THE TEAM STILL ON THE DEPLOYMENT DEVICE. THE PATIENT REQUIRED SURGERY TO REPAIR THE CECAL PERFORATION AT THE BASE OF THE APPENDIX. THIS REQUIRED A LENGTHENED HOSPITAL STAY. THE DEVICE AND PACKAGING WERE NOT SAVED, THEREFORE UNABLE TO DETERMINE WHETHER THIS WAS USER-ERROR, DEVICE MALFUNCTION, OR ANATOMY RELATED.