NUERA TIGHT

Additional Manufacturer Narrative

BIOS AND THE IMPORTER LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN, PATIENT TREATMENT SETTINGS, PATIENT INFORMATION AND PATIENT PHOTO. NO INCIDENT FORM OR PATIENT PHOTO HAS BEEN RECEIVED IN LUMENIS. THE DEVICE WAS INSTALLED ON AUGUST 20, 2021 AND IS BILLABLE. NO PM WAS PERFORMED SINCE THEN BASED ON DEVICE SERVICE HISTORY. LUMENIS HIGHLY RECOMMENDS AN ANNUAL PM CHECK IN A TIMELY MANNER TO ASSURE CONTINUED PROPER OPERATION OF THE DEVICE. INITIATIVE AND PAYMENT FOR THAT LIES ON CUSTOMER'S RESPONSIBILITY. ACCORDING TO THE TECHNICAL SUPPORT TEAM, IF THE SHIELDING IS DAMAGED OR WORN OUT IN ANY WAY, IT MUST BE REPLACED BY THE USER FACILITY. THE CUSTOMER HAS NOT REPORTED ANY DEVICE ERRORS, AND THE SYSTEM APPEARS TO BE FUNCTIONING PROPERLY. FOR THE NUERA 1.2 DEVICE, LUMENIS RECOMMENDS USING DISPOSABLE GROUNDING PADS ONLY. THE TECHNICAL SUPPORT TEAM HAS MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER TO DISCUSS THE REPORTED EVENT AND REVIEW TECHNICAL DATA. HOWEVER, THE CUSTOMER HAS BEEN LARGELY UNRESPONSIVE. ACCORDING TO THE CE, THE CUSTOMER CONTINUES TO USE THE DEVICE WITHOUT ANY ISSUES. THE CE ADVISED TRANSITIONING FROM REUSABLE GROUNDING PADS TO DISPOSABLE ONES, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. THE USER MANUAL INCLUDES THE FOLLOWING INSTRUCTION: "DISCARD THE SINGLE-USE RETURN PLATES AFTER EACH PATIENT USE. USE ONLY THE SINGLE-USE PLATES PROVIDED BY LUMENIS." WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A SERIOUS INJURY NOR MALFUNCTION HAD OCCURRED, BECAUSE OF THE LACK OF INFORMATION BIOS IS REPORTING THE EVENT IN AN 'ABUNDANCE OF CAUTION'. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

Description of Event or Problem

BIOS RECEIVED FROM LUMENIS (THE IMPORTER) THE NOTIFICATION ON AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BLISTER USING REUSABLE RETURN PLATE FOLLOWING TREATMENT BY NUERA DEVICE. ACCORDING TO THE PATIENT, THE REUSABLE GROUNDING PAD FELT HOT DURING THE TREATMENT.