BOA VISION

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, THE CUSTOMER COMPLAINED THAT THE INSTRUMENT DOES NOT HOLD ANY PRESSURE AND NOTICED LEAKING BLACK FLUID. THEY CLAIMED THAT THE DEVICE MAY HAVE POSSIBLY BEEN DAMAGED DURING THE PROCEDURE. THERE WAS NO REPORTED DELAY IN THE PROCEDURE AND NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED. THE SCHEDULED PROCEDURE WAS COMPLETED.

Additional Manufacturer Narrative

ALTHOUGH NO INJURIES OR UNACCEPTABLE RISKS TO THE PATIENT WERE REPORTED, RICHARD WOLF GMBH (RWGMBH) CONSIDER THIS CASE A "REPORTABLE MALFUNCTION" DUE TO A SIMILAR INCIDENT BEING REPORTED AS A "SERIOUS INJURY" IN THE PAST TWO YEARS.