SINGLE USE LOOP CUTTER FS-410

Description of Event or Problem

IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPY PROCEDURE, THE SINGLE USE LOOP CUTTER BECAME LODGED ON THE SUTURE INSIDE THE PATIENT. AS THE NURSE WENT TO CLOSE THE SUTURE CUTTER, THE HANDLE BECAME STUCK AND COULD NOT OPEN AND CLOSE. THE CUSTOMER CUT THE HANDLE AND PERFORMED EMERGENCY PROCEDURE AND USED A BIOPSY FORCEPS TO DISCONNECT THE SUTURE CUTTER FROM THE VICRYL SUTURE TO DETACH AND REMOVE THE FAULTY LOOP CUTTER FROM THE PATIENT. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED A GASTRIC BAND PROCEDURE WAS DONE ON THE PATIENT OVER A YEAR AGO. THE SUTURE WAS A STRONG THREAD AND WAS HANGING FOR A YEAR. THE SURGEON WAS ADVISED THE LOOP CUTTER WAS NOT THE CORRECT INSTRUMENT TO USE BY THE NURSE WHO ASSISTED THE PROCEDURE. HOWEVER, THE SURGEON INSISTED AND WANTED IT TO BE HEAVY HANDED. THE DEVICE WAS OVER SQUEEZED, AND IT SNAPPED. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

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