SURGICAL EYE TRAY

Additional Manufacturer Narrative

IT WAS REPORTED THAT, WHILE UNDERGOING A STRABISMUS SURGERY, BILATERAL LATERAL RECTUS RECESSION, THE FORCEPS HOLDING ONTO THE TISSUE POPPED OPEN AND FELL TO THE FLOOR. THE FORCEPS THAT FELL WERE NO USED AGAIN THROUGHOUT THE PROCEDURE; HOWEVER THE EVENT DID RESULT IN A DELAY IN THE PROCEDURE THAT REQUIRED ADDITIONAL ANESTHESIA TO BE ADMINISTERED. THE PATIENT MADE A FULL RECOVERY WITH NO FURTHER INCIDENT REPORTED. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY, AS A RESULT OF THE INCIDENT. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE CUSTOMER REPORTED ISSUE WAS NOT CONFIRMED. DUE TO THE REPORTED INCIDENT AND SUBSEQUENT NEED FOR ADDITIONAL ANESTHESIA THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

LOCKING FORCEPS WOULD NOT HOLD ONTO TISSUE RESULTING IN FORCEPS POPPING OFF IN THE MIDDLE OF A PROCEDURE.