SINGLE USE SURGICAL SCISSORS FS-200

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE COMPLAINT COULD NOT BE DIRECTLY REPRODUCED AS THE DEVICE WAS RETURNED IN SEPARATE PIECES AND THE REPORTED EVENT WAS NOT REPRODUCIBLE, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE REPORTED INFORMATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS TRACED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT DEVICE HAD SCISSORS THAT FAILED TO CUT AND WOULD NOT REOPEN, RESULTING IN ENTRAPMENT OF BOTH THE SUTURE AND THE SURROUNDING MUCOSA. THE ISSUE WAS FOUND DURING SEDATION OF ESOPHAGOGASTRODUODENOSCOPY (EGD) THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A CHANGE IN PROCEDURE/SURGICAL TECHNIQUE. THERE WERE NO REPORTS OF PATIENT HARM.