GRIESHABER REVOLUTION DSP FORCEPS

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).

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC FORCEPS ACTUATOR WAS NOT FUNCTIONING PROPERLY, WAS NOT SECURELY TIGHTENED, AND INTERMITTENTLY INTERRUPTED DURING A VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE FORCEPS, AND NO PATIENT HARM WAS REPORTED.