GRIESHABER REVOLUTION DSP FORCEPS

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC FORCEPS FAILED TO OPEN DURING A SCHEDULED VITRECTOMY PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE INSTRUMENT. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).