TC MAYO-HEGAR NH 8 MATTE
Received Dec 9, 2011
Report 2523190-2011-00085 · MDR key 2406352
Device
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
THE CUSTOMER INITIALLY REPORTED THAT A PIECE OF CARB-BITE BROKE OFF OF NEEDLE DRIVER. THE MISSING PIECE WASN'T DISCOVERED UNTIL AFTER THE SURGERY WHEN THE INSTRUMENT WAS BEING PROCESSED. AN X-RAY WAS TAKEN AND THE FOREIGN BODY WAS LOCATED, THE PT WAS TAKEN BACK TO THE OPERATING ROOM FOR ITS REMOVAL. ON (B)(6) 2011, THE OPERATING ROOM MANAGER REPORTED THAT THE FIRST PROCEDURE WAS A VAGINAL HYSTERECTOMY. THE SECOND SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE MISSING PIECE OF THE CARB-BITE INSERT FROM THE VAGINAL CUFF USING A SUCTION TIP. A POSTOPERATIVE X-RAY CONFIRMED THAT ALL PIECES OF THE INSERT WERE REMOVED. HOSPITAL RISK MANAGEMENT HAS THE INSTRUMENT.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. HOSPITAL RISK MANAGEMENT HAS THE INSTRUMENT. IT'S RETURN FOR INVESTIGATION HAS BEEN REQUESTED.