SINGLE FUNCTION ABC PENCIL

Additional Manufacturer Narrative

THE DEVICE IS NOT BEING RETURNED AND NO PHOTOGRAPH EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. A LOT HISTORY REVIEW COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF TWO COMPLAINTS, REGARDING TWO DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO AVOID BURNS NEVER ALLOW CABLE ASSOCIATE WITH THIS DEVICE TO BE IN CONTACT WITH SKIN OF PATIENT OR TOUCHING OPERATOR. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. NOTE: THIS REPORT IS BEING RESUBMITTED FOLLOWING AN UNSUCCESSFUL SUBMISSION ATTEMPT ON DATE DUE TO A SYSTEM ERROR. DEVICE DISPOSED OF AT HOSPITAL.

Description of Event or Problem

THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 130344 WAS BEING USED DURING AN UNKNOWN TYPE OF PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED ¿WHEN ¿ABC HANDPIECE-130344" WAS NOT IN USE, ABC HANDPIECE OUTPUTTED AND THE BEAM HIT THE SURGEON, CAUSING BURNS ON THE SURGEON'S ARM.¿ FURTHER ASSESSMENT INFORMATION WAS REQUESTED, INCLUDING THE DEGREE OF BURN; HOWEVER, THE REPORTER RESPONDED THAT THIS INFORMATION WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE USER. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN TO USER.