SINGLE USE LOOP CUTTER FS-410

Description of Event or Problem

IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) A LOOP CUTTER WAS USED TO CUT A 5 FRENCH ENDOSCOPIC NASO-PANCREATIC DRAINAGE (ENPD) TUBE. THE DEVICE WAS DAMAGED AND BECAME STUCK IN THE ENDOSCOPE MAIN BODY. SPECIFICALLY, THE WIRE IN THE CONTROL SECTION WAS DEFORMED AND THE LOOP CUTTER REMAINED OPEN. THE SCOPE WAS EXTRACTED FROM THE PATIENT WITH THE LOOP CUTTER FORCEPS STUCK IN THE ENDOSCOPE TIP DUE TO AN ATTEMPT TO PULL THE LOOP CUTTER INTO THE ENDOSCOPE FORCEPS HOLE WHILE IT WAS OPEN. AT THIS POINT, THE DESIRED PROCEDURE WAS COMPLETED AND THERE WAS NO IMPACT ON THE PATIENT. WHEN CLEANING THE ENDOSCOPE AFTER THE EXAMINATION, PLIERS WERE USED TO CUT THE INSERTION SECTION NEAR THE FORCEPS PORT IN ORDER TO REMOVE THE LOOP CUTTER FROM THE DISTAL END OF THE ENDOSCOPE. A WIRE THAT PROTRUDED FROM THE SEVERED SECTION LODGED INTO THE ENDOSCOPY TECHNICIAN'S RIGHT THUMB. SINCE THE DEVICE WAS CONTAMINATED WITH BODILY FLUIDS, THE ENDOSCOPY TECHNICIAN FOLLOWED UP WITH BLOOD DRAWS AND OTHER FOLLOW-UP PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED AND THE ENDOSCOPY TECHNICIAN WHO WAS INJURED STATED THE INJURY HAD ABSOLUTELY NO IMPACT ON HIM AT THIS TIME. ADDITIONALLY, THE ENDOSCOPY TECHNICIAN CONFIRMED THEY WERE NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT, ONLY GLOVES. IT WAS ALSO REPORTED THAT THE DOCTOR WHO USED THE PRODUCT STATED THEY UNDERSTOOD THE USE OF THE LOOP CUTTERS WAS OFF LABEL, BUT THERE ARE CASES WHERE IT IS UNAVOIDABLE TO USE THEM AS THERE IS CURRENTLY NO DEDICATED DEVICE FOR CUTTING. THEREFORE, THEY HAD NO CHOICE BUT TO USE IT. THE DOCTOR STATED THE OLYMPUS SALES STAFF HAD NEVER RECOMMENDED THIS KIND OF USE, AND THEY DID NOT SUSPECT THERE WAS ANYTHING ABNORMAL WITH THE ENDOSCOPE OR INSTRUMENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.