Description of Event or Problem · 0
HEALER MEDICAL, INC. IS REPORTING SERIOUS CONCERNS REGARDING THE HANDLING AND SERVICING OF REGULATED MEDICAL DEVICES BY HISTOSONICS, INC., A MEDICAL DEVICE MANUFACTURER, INVOLVING TWO EDISON SYSTEMS USED IN A CLINICAL SETTING FOR THE TREATMENT OF LIVER CANCER PATIENTS, INCLUDING PATIENTS WITH ADVANCED-STAGE CONDITIONS. THE ISSUES DESCRIBED HAVE RESULTED IN SIGNIFICANT DISRUPTION TO CLINICAL OPERATIONS AND HAVE IMPACTED THE AVAILABILITY OF TREATMENT FOR PATIENTS. AT PRESENT, BOTH SYSTEMS ARE NON-OPERATIONAL. 1. DEVICE OPERATION. 1.1 MACHINE A. BASED ON OUR INTERNAL RECORDS, ON DECEMBER 12, 2025, A SERVICE CREW ASSOCIATED WITH THE MANUFACTURER ENTERED OUR FACILITY AND REMOVED CRITICAL COMPONENTS OF THE EDISON SYSTEM, INCLUDING TWO TREATMENT HEADS AND THE MAIN SYSTEM UNIT WITHIN THE TREATMENT CART, WITHOUT PRIOR NOTIFICATION, AUTHORIZATION, OR DOCUMENTATION. FOLLOWING THIS EVENT, MACHINE A WAS LEFT INCOMPLETE AND NON-FUNCTIONAL. NO NOTIFICATION OR DOCUMENTATION WAS PROVIDED TO OUR FACILITY REGARDING THIS CHANGE IN DEVICE STATUS. AS A RESULT, FROM (B)(6) 2025 THROUGH (B)(6) 2026, WE WERE UNAWARE THAT CRITICAL COMPONENTS HAD BEEN REMOVED AND THAT THE SYSTEM WAS NO LONGER FUNCTIONAL. DUE TO THE ABSENCE OF ANY VISIBLE INDICATION OF SYSTEM IMPAIRMENT, THE DEVICE APPEARED EXTERNALLY INTACT AND OPERATIONAL, AND CLINICAL WORKFLOW, INCLUDING PATIENT SCHEDULING AND TREATMENT PREPARATION, CONTINUED UNDER THE ASSUMPTION THAT THE SYSTEM WAS AVAILABLE FOR USE. THE ISSUE WAS ONLY IDENTIFIED AT THE POINT OF INTENDED CLINICAL USE, WHEN THE SYSTEM COULD NOT BE POWERED ON OR OPERATED. THIS LACK OF TRANSPARENCY REGARDING DEVICE STATUS CREATED A HIGH-RISK SITUATION IN A CLINICAL ENVIRONMENT. AFTER THIS DISCOVERY, FROM EARLY MARCH 2026, MULTIPLE REQUESTS FOR CLARIFICATION AND SERVICE SUPPORT WERE MADE. WHILE INTERMITTENT RESPONSES WERE RECEIVED, THE MANUFACTURER DID NOT RESTORE THE SYSTEM OR RETURN THE REMOVED COMPONENTS, AND THE ISSUE REMAINED UNRESOLVED. IN ADDITION, AFTER WE FORMALLY REQUESTED THE RETURN OF THE REMOVED COMPONENTS AND RESTORATION OF THE SYSTEM, HISTOSONICS ISSUED A UNILATERAL TERMINATION NOTICE. THIS TERMINATION OCCURRED WHILE THE SYSTEM REMAINED NONFUNCTIONAL AND BEFORE ANY RESTORATION OR RETURN OF CRITICAL COMPONENTS, FURTHER PROLONGING THE PERIOD DURING WHICH THE DEVICE WAS UNAVAILABLE FOR CLINICAL USE. 1.2 MACHINE B. A SECOND EDISON SYSTEM REMAINS NON-OPERATIONAL DUE TO THE MANUFACTURER¿S FAILURE TO COMPLETE REQUIRED SYSTEM UPGRADES NECESSARY FOR PATIENT TREATMENT. SINCE EARLY DECEMBER 2025, REPEATED REQUESTS FOR THESE UPGRADES HAVE BEEN MET WITH DELAYS AND JUSTIFICATIONS RATHER THAN COMPLETION OF THE REQUIRED WORK. AS A RESULT, MACHINE B HAS NOT BEEN MADE AVAILABLE FOR CLINICAL USE. THIS RAISES CONCERNS REGARDING THE MANUFACTURER¿S ABILITY TO MAINTAIN DEVICE READINESS AND ENSURE THAT DISTRIBUTED SYSTEMS REMAIN OPERATIONAL IN A CLINICAL SETTING. 2. TRACEABILITY & DOCUMENTATION; 2.1 MACHINE A. THE REMOVAL OF CRITICAL COMPONENTS FROM MACHINE A WAS NOT ACCOMPANIED BY ANY DOCUMENTATION, SERVICE RECORDS, OR FORMAL NOTIFICATION. THERE IS NO CLEAR RECORD OF: THE REMOVAL ACTIVITY, THE CURRENT LOCATION OR STATUS OF THE REMOVED COMPONENTS. THE COMPONENTS HAVE NOT BEEN RETURNED, AND NO DOCUMENTED SERVICING HAS BEEN COMPLETED. THIS LACK OF DOCUMENTATION AND ACCOUNTABILITY RAISES CONCERNS REGARDING TRACEABILITY AND CONTROL OF REGULATED MEDICAL DEVICES AND MAY NOT BE CONSISTENT WITH APPLICABLE REQUIREMENTS UNDER 21 CFR PART 820, INCLUDING THOSE RELATED TO DISTRIBUTION AND INSTALLATION CONTROLS. IN ADDITION, THE ABSENCE OF DOCUMENTED SERVICING ACTIVITY MAY RAISE CONCERNS UNDER 21 CFR § 820.200. 2.2 MACHINE B. FOR MACHINE B, THERE IS NO DOCUMENTED COMPLETION OF REQUIRED SYSTEM UPGRADES, AND NO CLEAR SERVICING RECORDS DEMONSTRATING THAT NECESSARY UPDATES HAVE BEEN PERFORMED. REPEATED DELAYS WITHOUT RESOLUTION FURTHER RAISE CONCERNS REGARDING GAPS IN SERVICING DOCUMENTATION, MAINTENANCE CONTROL, AND OVERALL ACCOUNTABILITY FOR DEVICE READINESS. 3. PATIENT SAFETY & CLINICAL IMPACT. THE EDISON SYSTEMS ARE USED IN THE TREATMENT OF LIVER CANCER PATIENTS, INCLUDING PATIENTS WITH ADVANCED-STAGE CONDITIONS WHO RELY ON TIMELY AND CONTINUOUS ACCESS TO TREATMENT. DUE TO BOTH SYSTEMS BEING NON-OPERATIONAL, SCHEDULED TREATMENTS HAVE BEEN DELAYED OR INTERRUPTED, AND CLINICAL SCHEDULING HAS BEEN SIGNIFICANTLY DISRUPTED. PATIENTS CONTINUED THROUGH SCHEDULING AND PREPARATION PROCESSES UNDER THE ASSUMPTION THAT TREATMENT SYSTEMS WERE AVAILABLE, AND IN SOME CASES, THE UNAVAILABILITY OF THE SYSTEM WAS ONLY IDENTIFIED AT THE POINT OF INTENDED USE. THIS SITUATION HAS CREATED UNCERTAINTY AND DISRUPTION IN TREATMENT PLANNING, PARTICULARLY FOR PATIENTS WITH SERIOUS AND TIME-SENSITIVE CONDITIONS. DELAYS IN TREATMENT AVAILABILITY MAY ADVERSELY IMPACT CONTINUITY OF CARE AND THE ABILITY TO DELIVER TIMELY INTERVENTIONS. IN ADDITION, THE LACK OF TRANSPARENCY REGARDING DEVICE STATUS, COMBINED WITH PROLONGED DELAYS IN SERVICING AND RESOLUTION, HAS FURTHER CONTRIBUTED TO UNCERTAINTY IN CLINICAL OPERATIONS AND PATIENT MANAGEMENT. CONCERN: IMPACT ON CONTINUITY OF CARE; DISRUPTION TO TIME-SENSITIVE TREATMENT PLANNING; UNCERTAINTY IN TREATMENT AVAILABILITY; RELIABILITY OF DEVICE SUPPORT IN A CLINICAL ENVIRONMENT; CONDUCT THAT APPEARS MISLEADING AND HAS RESULTED IN THE INABILITY TO PROVIDE SCHEDULED PATIENT TREATMENTS. WE ARE SUBMITTING THIS REPORT FOR FDA REVIEW, AS THE MANUFACTURER¿S ACTIONS DESCRIBED ABOVE APPEAR INCONSISTENT WITH APPLICABLE REGULATORY REQUIREMENTS AND HAVE ALREADY RESULTED IN SIGNIFICANT DISRUPTION TO CLINICAL OPERATIONS AND PATIENT TREATMENT AVAILABILITY. THESE ISSUES WARRANT FURTHER REGULATORY REVIEW AND INVESTIGATION. REF REPORT: MW5186079.