Description of Event or Problem · 1
ON OCTOBER 24, 2019 LEICA MICROSYSTEMS, INC. (FDA REGISTRATION (B)(4)) RECEIVED A USER FACILITY MEDWATCH FORM FDA 3500A REPORT ((B)(4)) FROM THE AGENCY IN REGARD TO A REPORTED PATIENT BURN AT THE (B)(6) HOSPITAL AND MEDICAL CENTER IN (B)(6) USA. IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND OUR APPROVED EXEMPTION FORM (ATTACHMENT E2011008), LEICA MICROSYSTEMS, INC. FORWARDED THIS MEDWATCH REPORT TO THE LEGAL MANUFACTURER OF THE MICROSCOPE IN QUESTION, LEICA MICROSYSTEMS (B)(4). LEICA MICROSYSTEMS, INC. CONTACTED THE INITIATOR, (B)(6) (BIOMEDICAL ENGINEER - (B)(6)), TO INQUIRE ABOUT THE SOURCE OF THIS COMPLAINT. MR. (B)(6) INDICATED THAT THIS PARTICULAR INCIDENT HAD BEEN INVESTIGATED IN AUGUST BY LEICA REPRESENTATIVES AND THAT HE WAS FILING THIS REPORT IN OCTOBER. LEICA SALES REPRESENTATIVES WERE CONTACTED ABOUT THIS INCIDENT AS THE MODEL NUMBER OF THE MICROSCOPE DIFFERED FROM THE PREVIOUSLY REPORTED COMPLAINT. THEY WERE NOT AWARE OF AN INCIDENT WITH THE MODEL OF MICROSCOPE STATED IN THE USER FACILITY MEDWATCH FORM. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE INCIDENT REPORTED IN USER FACILITY MEDWATCH ((B)(4)) WAS FILED IN ERROR AS THIS INCIDENT WAS THE SAME PREVIOUSLY REPORTED TO LEICA MICROSYSTEMS, INC. ON JULY 31ST, 2019. LEICA MICROSYSTEMS, INC. PREVIOUSLY HAD BEEN NOTIFIED OF A PATIENT INCIDENT AT (B)(6) HOSPITAL, (B)(4) ON (B)(6) 2019. AN INTERNAL COMPLAINT WAS FILED FOR A REPORTED PATIENT BURN AT THIS HOSPITAL. THE AFFECTED LEICA SURGICAL MICROSCOPE WAS AN ARVEO. THIS INCIDENT WAS INVESTIGATED PER LEICA MICROSYSTEMS, INC. PROCEDURES AND IT WAS DETERMINED THAT THE ARVEO SURGICAL MICROSCOPE DEVICE UNLIKELY CAUSED OR CONTRIBUTED TO PATIENT INJURY AND THEREFORE, THE COMPLAINT WAS NOT REPORTABLE TO THE US-FDA IN ACCORDANCE TO 21 CFR 803.50. THIS PARTICULAR EVENT WAS REPORTED TO FDA BY THE LEGAL MANUFACTURER, LEICA MICROSYSTEMS (B)(4), UNDER MDR 3003974370-2019-00013. SINGLE MDR EXEMPTION: LEICA MICROSYSTEMS, INC. RECEIVED EMAIL CORRESPONDENCE FROM FDA ON 25 NOV 2020 IN REGARD TO A LETTER SENT TO LEICA MICROSYSTEMS, INC. ON 9 NOV 2018 INSTRUCTING LEICA MICROSYSTEMS, INC. TO CEASE SUBMISSION OF SINGLE MDR'S PER THIS EXEMPTION. LEICA MICROSYSTEMS, INC. RESPONDED TO FDA ON 30 NOV 2020 INDICATING THAT THIS LETTER WAS NOT RECEIVED AS THE ADDRESS OF LEICA MICROSYSTEMS, INC. WAS INCORRECT. THIS INCIDENT IS AN MDR REPORTABLE EVENT UNDER 21 CFR PARTS 803.40 AND 803.32. THIS MDR ACCOUNTS FOR THE IMPORTER REQUIREMENTS UNDER THESE REGULATIONS.