TULOC

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. H3: THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE. THE DEVICE HAS BEEN DISCARTED BY THE CUSTOMER, THUS IT WILL NOT BE RETURNED FOR INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A MARKING OF BREAST LESION USING A TULOC DEVICE, A PATIENT HAD TO BE OPERATED ON TWICE, DUE TO THE DEVICE DISLOCATED AND WAS BEING STUCK IN THE INCORRECT POSITION. BETWEEN THE 1ST AND 2ND PROCEDURE APPROXIMATELY 6 WEEKS TRANSPIRED. THE WIRE COULD NOT BE REMOVED FROM THE PATIENT IN QUESTION AS IT HAD SHORTENED AFTER BEING IN THE FIRST POSITION. NO OTHER INFORMATION IS AVAILABLE.