TRUNODE

Additional Manufacturer Narrative

LOT NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. 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.

Additional Manufacturer Narrative

DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED AT THE TIME OF THIS REPORT A FOLLOW UP MDR WILL FOLLOW WITH THE DHR INFORMATION. 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.

Description of Event or Problem

IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER A TRUNODE PROCEDURE WHICH WAS RELATED TO COLON CANCER, THE PATIENT PRESENTED WITH INFECTION WHICH REQUIRED ORAL MEDICATION AND THAT THE INFECTION WAS IMPROVING. IT WAS REPORTED THAT THERE WAS A CROSS-CONTAMINATION DUE TO THE REUSE OF THE TRUNODE GAMMA PROBE. MULTIPLE ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION WERE NOT RESPONDED. NO OTHER INFORMATION RECEIVED.

Additional Manufacturer Narrative

AN INVESTIGATION WAS CONDUCTED: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER A TRUNODE PROCEDURE WHICH WAS RELATED TO COLON CANCER, THE PATIENT PRESENTED WITH INFECTION WHICH REQUIRED ORAL MEDICATION AND THAT THE INFECTION WAS IMPROVING. IT WAS REPORTED THAT THERE WAS A CROSS-CONTAMINATION DUE TO THE REUSE OF THE TRUNODE GAMMA PROBE. MULTIPLE ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION WERE NOT RESPONDED. NO OTHER INFORMATION RECEIVED. THE DEVICE WAS NOT AVAILABLE FOR RETURN; VISUAL AND FUNCTIONAL ANALYSIS/TESTING COULD NOT BE CONDUCTED FOR THE DESCRIBED EVENT. THIS COMPLAINT WAS IDENTIFIED AS PART OF THE DATA REVIEWED DURING THE PMCF REPORT, WHICH LED TO THE INITIATION OF AN NCE AND SUBSEQUENTLY A CAPA. THE CAPA WAS OPENED TO ADDRESS A PROCESS GAP IDENTIFIED IN HOW DATA FROM PMCF STUDIES ARE MANAGED WHEN POTENTIAL REPORTABLE EVENTS ARE DETECTED. WHILE THE CAPA FOCUSED ON PROCESS IMPROVEMENTS RELATED TO COMPLAINT IDENTIFICATION AND ESCALATION, THE CURRENT INVESTIGATION ADDRESSES THE SPECIFIC DEVICE AND CLINICAL ASPECTS OF THIS COMPLAINT (INFECTION ASSOCIATED WITH TRUNODE GAMMA PROBE). THE DEVICE WAS NOT AVAILABLE FOR RETURN; VISUAL AND FUNCTIONAL ANALYSIS/TESTING COULD NOT BE CONDUCTED FOR THE DESCRIBED EVENT. THE DEVICE WAS NOT RETURNED FOR THIS COMPLAINT AND THERE WAS LIMITED PATIENT-RELATED INFORMATION PROVIDED FOR THIS EVENT; THEREFORE, A THOROUGH INVESTIGATION WAS NOT CARRIED OUT. INVESTIGATION FOR THIS ISSUE WAS CONDUCTED THROUGH CUSTOMER PROVIDED INFORMATION, HISTORICAL DATA REVIEW, SIMILAR COMPLAINTS ANALYSIS, AND PRODUCT DESIGN EVALUATION. WITHOUT THE RETURNED DEVICE, IT IS NOT POSSIBLE TO CONFIRM A DEFINITIVE ROOT CAUSE OF THE ISSUE. CONCLUSION: THIS EVENT WAS PART OF THE 6 COMPLAINTS IDENTIFIED DURING PMCF DATA REVIEW THAT LED TO AN NCE AND CAPA. THE PROCESS-RELATED GAP IDENTIFIED IN THOSE RECORDS HAS SINCE BEEN ADDRESSED THROUGH THE IMPLEMENTATION OF WORK INSTRUCTION, ENSURING TIMELY ESCALATION OF POTENTIAL COMPLAINTS DERIVED FROM PMCF DATA. THE CURRENT INVESTIGATION THEREFORE FOCUSES SOLELY ON THE CLINICAL OUTCOME AND DEVICE-RELATED ASPECTS OF THIS INDIVIDUAL CASE. THE REPORTED ISSUE COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED. HRA/SCAR OR ADDITIONAL CAPA OR NCE ARE NOT DEEMED REQUIRED AT THIS MOMENT BY THIS EVENT. FUTURE EVENTS WILL BE MONITORED AND TRENDED. DEVICE HISTORY RECORD (DHR) REVIEW: THE DHR REVIEW WAS NOT CONDUCTED SINCE THE LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE COMPLAINANT.