MalfunctionEMG
PLANERT CROWN DILATING FORCEPS 140MM
Received Apr 23, 2019
Report 9610612-2019-00280 · MDR key 8541701
Device
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PLANERT CROWN-DILATING FORCEP. DURING A DENTAL PROCEDURE, THE INSTRUMENT BROKE. THERE WAS NO DELAY OR INJURY AND NO INTERVENTION NEEDED. ADDITIONAL INFORMATION WAS NOT PROVIDED.