HU-FRIEDY 13/14L COLUMBIA UNIVERSITY CURETTE

Description of Event or Problem

PT WENT FOR A ROUTINE CLEANING AND DURING THE PROCEDURE THE TIP OF THE INSTRUMENT ((B)(4)) BROKE IN THE PT'S MOUTH AND THE PT SWALLOWED THE TIP. PT WENT TO THE HOSPITAL AFTER THE INCIDENT, THE HOSPITAL PERFORMED AN X-RAY TO CONFIRM THE TIP HAD BEEN SWALLOWED AND SUBSEQUENTLY DID AN ENDOSCOPIC PROCEDURE TO REMOVE THE BROKEN PIECE. DUE TO THE AGE OF THE PT, THE HOSPITAL DID NOT WANT TO WAIT TO SEE IF THE TIP WOULD PASS NATURALLY AND FELT THE NEED TO REMOVE IT.

Additional Manufacturer Narrative

WEIGHT OF PT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE THE INFO. (B)(4) DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT # WHICH IS TIED TO THE DATE OF MANUFACTURE. SINCE THE INSTRUMENT WAS NOT RETURNED WE WERE NOT ABLE TO DETERMINE THE LOT NUMBER. THE PRODUCT INVOLVED IN THE EVENT WAS A STAINLESS STEEL INSTRUMENT THAT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE.