MICRO DEBRIDER
Received Jul 9, 2015
Report 8031010-2015-00026 · MDR key 4910103
Device
Product problems
- Break
- Component Falling
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVOLVED PRODUCT WAS NOT RETURNED AND CANNOT BE ANALYZED. THE PROVIDED BATCH NUMBER TURNS OUT TO HAVE NO CORRESPONDING WITH THE INVOLVED PRODUCT CATALOG NUMBER. THE RIGHT BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A MICRO DEBRIDER BROKE DURING USE. THE BROKEN PIECE WAS RETRIEVED WITH A SALIVA EJECTOR.
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION WITH A SIMILAR DEVICE RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.