#7/8 GRACEY CURETTE, #7 HANDLE, GREEN
Received Jun 17, 2022 · Event occurred Jun 2, 2022
Report 1416605-2022-00007 · MDR key 14733340
Device
Product problems
- Break
- Break
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE SUBJECT OF THE EVENT WAS RETURNED FOR EVALUATION AND THE BREAKAGE WAS CONFIRMED AT THE BLADE BEND ANGLE. THE APPEARANCE OF THE SURFACE WHERE THE BREAK OCCURRED AS WELL AS THE LOCATION OF THE BREAK AT THE BLADE BEND ANGLE ARE INDICATIVE OF THE DEVICE BEING SUBJECTED TO IMPACT DAMAGE. THE DEVICE MAY HAVE BEEN DROPPED OR MISHANDLED BY USER FACILITY PERSONNEL. THE DAMAGE TO THE DEVICE CAUSED THE TIP TO DETACH RESULTING IN THE REPORTED EVENT. THE DEVICE HISTORY RECORD OF THE LOT SUBJECT OF THE EVENT WAS REVIEWED AND NO ABNORMALITIES WERE FOUND. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE TIP OF THEIR GRACEY CURETTE DETACHED IN THE PATIENT'S MOUTH DURING A DENTAL PROCEDURE AND THE PATIENT SWALLOWED THE TIP. THE TIP OF THE GRACEY CURETTE WAS REMOVED FROM THE PATIENT DURING A SUBSEQUENT ENDOSCOPIC PROCEDURE.