FLUOBEAM LX

Additional Manufacturer Narrative

A REVIEW OF INTERNAL COMPLAINT DATA IDENTIFIED SIMILAR EVENTS, INCLUDING OCCURRENCES IN DIFFERENT GEOGRAPHICAL REGIONS. THESE EVENTS INVOLVE LOCALIZED DAMAGE TO SURGICAL DRAPES WHEN THE DEVICE IS IN AN ACTIVATED STATE (OPTICAL HEAD WITH ALL LIGHT SOURCES ON) AND IN CONTACT OR CLOSE PROXIMITY TO DRAPE MATERIALS. AN INVESTIGATION HAS BEEN INITIATED. PRELIMINARY ANALYSIS INDICATES THAT THE DEVICE PERFORMS ACCORDING TO ITS INTENDED DESIGN SPECIFICATIONS. HOWEVER, UNDER CERTAIN USE CONDITIONS, INCLUDING PROLONGED CONTACT WITH MATERIALS WHILE ACTIVATED (OPTICAL HEAD WITH ALL LIGHT SOURCES ON), LOCALIZED HEATING EFFECTS MAY OCCUR. THE INVESTIGATION ALSO CONSIDERS USE CONDITIONS AND USER INTERACTION, INCLUDING PLACEMENT OF THE ACTIVATED DEVICE ON STERILE SURGICAL DRAPES. THE ADEQUACY OF CURRENT LABELING AND INSTRUCTIONS FOR USE TO COMMUNICATE THIS RISK IS UNDER EVALUATION. NO ROOT CAUSE HAS BEEN DEFINITIVELY ESTABLISHED AT THIS STAGE. NO PATIENT OR USER INJURY HAS BEEN REPORTED IN ANY OF THE IDENTIFIED CASES. HOWEVER, THE OBSERVED DAMAGE TO THE DRAPE MAY POTENTIALLY RESULT IN A BREACH OF STERILITY IF NOT DETECTED. CORRECTIVE ACTIONS ARE BEING CONSIDERED, INCLUDING UPDATES TO THE INSTRUCTIONS FOR USE TO IMPROVE RISK COMMUNICATION. ADDITIONAL USER COMMUNICATION MEASURES ARE CURRENTLY UNDER EVALUATION. THE INVESTIGATION REMAINS ONGOING. THE MANUFACTURER WILL PROVIDE UPDATED INFORMATION IF SIGNIFICANT FINDINGS OR ADDITIONAL ACTIONS ARE IDENTIFIED.

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF ADDITIONAL INFORMATION THROUGH AN FDA MEDWATCH (MDR REPORT MW5187819 / MDR REPORT KEY (B)(4) REPORT INVOLVING A FLUOBEAM LX FLUORESCENCE IMAGING SYSTEM DURING A SURGICAL PROCEDURE. ACCORDING TO THE REPORT, THE DEVICE, WHILE IN AN ACTIVATED STATE (OPTICAL HEAD WITH ALL LIGHT SOURCES ON), WAS PLACED IN CONTACT WITH A SURGICAL DRAPE. THIS RESULTED IN LOCALIZED DAMAGE TO THE DRAPE, INCLUDING THE FORMATION OF A HOLE. ALTHOUGH NO PATIENT OR USER HARM WAS REPORTED, BASED ON THE POTENTIAL RISK OF INFECTION ASSOCIATED WITH A STERILE BARRIER BREACH AND THE POSSIBILITY THAT THE DEVICE CONTRIBUTED TO THIS EVENT, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. THE EVENT WAS IDENTIFIED DURING OR SHORTLY AFTER USE. THE DAMAGED AREA OF THE DRAPE WAS VISUALLY OBSERVABLE. THE DEVICE WAS BEING USED IN A CLINICAL ENVIRONMENT AT THE TIME OF THE EVENT.