Description of Event or Problem · 0
DEAR SIR OR MADAM, I AM WRITING AS (B)(6). WE HAVE EXPERIENCED MULTIPLE SERIOUS SAFETY ISSUES WITH THE (B)(4). THAT IS NOW CLEARED BY FDA FOR MARKETING IN THE UNITED STATES. BETWEEN 2023 AND 2025, WE DOCUMENTED REPEATED (B)(6), INCLUDING: SEVERAL INCIDENTS OF (B)(6) DURING PRIMING (NO PATIENT INJURY BUT CLEAR DEVICE MALFUNCTION). A SERIOUS INTRAOPERATIVE INCIDENT IN (B)(6) 2024 IN WHICH (B)(6), REQUIRING SURGICAL MANAGEMENT. FOR THESE EVENTS WE OPENED MANUFACTURER CASES (B)(4) WITH THE (B)(4) MANUFACTURER OR AUTHORISED REPRESENTATIVE. THE (B)(6) WERE SENT TO THEM FOR INVESTIGATION, AND WE COMPLETED A MANUFACTURER INCIDENT REPORT (MIR) AT THEIR REQUEST. HOWEVER: DESPITE REPEATED WRITTEN REMINDERS, THE MANUFACTURER HAS REFUSED TO SUBMIT MIRS/MDRS FOR THESE SERIOUS EVENTS TO THE (B)(6) AND HAS INFORMED US THAT CASE (B)(4) IS CLOSED WITH NO MIR TO BE FILED. WE HAVE NOT RECEIVED ANY INVESTIGATION REPORT, ROOT-CAUSE ANALYSIS, CORRECTIVE OR PREVENTIVE ACTIONS, OR EVIDENCE THAT THESE SERIOUS (B)(6) HAVE BEEN REPORTED TO FDA UNDER 21 CFR PART 803.