THD LIGHT-SCOPE PROCTO HRA

Additional Manufacturer Narrative

THE DEVICE INVOLVED IS THD LIGHTSCOPE PROCTO HRA, REF 800191 - LOT 089021. BASED ON THE PICTURE RECEIVED BY THD COMPLAINT UNIT IT IS HIGHLIGHTED THE PRESENCE, INSIDE THE DEVICE ENVELOPE, OF A FOREIGN BODY. AT CLOSER OBSERVATION THIS WAS AN INSECT OR LARVA FROM AN INSECT AND THE PRESENCE OF A BREAK IN THE PACKAGE OF THE DEVICE. PLEASE ALSO NOTE THAT THE DEVICE IS A NON-STERILE MEDICAL DEVICE. THD SPA PERFORMED THE VERIFICATION OF THD LIGHTSCOPE PROCTO HRA DEVICE, LOT 089021, MANUFACTURING RECORDS WITHOUT FINDING ANY ANOMALIES, THE BATCH WAS RELEASED CONFORM FOR DISTRIBUTION, AND NO PROBLEMS WERE DETECTED DURING THE MANUFACTURING PROCESS IN THE ENVELOPES USED FOR PACKAGING THAT ARE 100% CONTROLLED DURING PACKAGING PROCEDURE. FOLLOWING THE REPORT RECEIVED, ON THE SAME DAY THD SPA VERIFIED ALL THE STOCK BATCHES PRESENT FOR REF 800191 AND DID NOT FOUND ANY ANOMALY ON THE 260 DEVICES AVAILABLE IN THE STOCK AT THD SPA WAREHOUSE. THE SAME INVESTIGATION HAS BEEN REQUESTED TO THD AMERICA INC (USA IMPORTER) THAT VERIFIED ALL THE STOCK BATCHES PRESENT FOR REF 800191 AND DID NOT FOUND ANY ANOMALY ON THE 450 DEVICES AVAILABLE IN THE STOCK AT THD AMERICA INC WAREHOUSE. AFTER TRACEABILITY PERFORMED BY THD SPA ON THE LOT 08921, THE SAME INVESTIGATION HAS BEEN REQUESTED TO THE ONLY DISTRIBUTOR THAT STILL HAD LOT 089021 OF THD LIGHTSCOPE PROCTO HRA, REF 800191 IN STOCK, THE SPANISH DISTRIBUTOR. IT HAD IN STOCK 140 PCS OF THE 500 PCS THAT ARE PART OF THE LOT. ALSO SPANISH DISTRIBUTOR CONFIRMED THAT NO DEVICE OF THE 140 DEVICES CHECKED HAD PACKAGING BREAKAGE AND PRESENCE OF INSECT INSIDE. THUS THE INVESTIGATION PERFORMED BY THD SPA AND THD AMERICA, ON IN STOCK DEVICES, FROM DIFFERENT BATCHES, AND ON THE SAME LOT NUMBER 089021, DIDN'T FIND ANY ANOMALY FOR THE PRIMARY AND SECONDARY PACKAGING OF THE DEVICES THAT ARE INTACT FOR ALL THE 850 DEVICES CONTROLLED AND NO FOREIGN BODIES ARE VISIBLE INSIDE THE SEALED BAGS. THIS CONFIRMS THAT THE FOREIGN BODY (LARVA) INSIDE THE DEVICE THAT WAS AT MOUNT SINAI, IS NOT FROM THD PRODUCTION BUT RATHER FROM AN EVENT THAT OCCURRED DURING TRANSPORTATION OR HANDLING AT THE HOSPITAL SPACE, BECAUSE THERE IS NO EVIDENCE OF ANOMALIES OCCURRED DURING NORMAL PRODUCTION PROCEDURES AND TRANSPORT TO DISTRIBUTORS IN EUROPE AND ALSO TO THD AMERICA ON MORE THAN 850 DEVICES VERIFIED AFTER THE EVENT. AN EVALUATION OF THE POSSIBLE PRESENCE OF SIMILAR EVENTS IN THE HISTORY OF THE PRODUCT WAS THEN CARRIED OUT THROUGH AN ANALYSIS OF THE COMPLAINTS DATABASE IN ORDER TO VERIFY POSSIBLE RE-OCCURRENCES OF THIS EVENT ON THE SAME PRODUCT CODE (REF 800191) AND THIS ANALYSIS DID NOT HIGHLIGHT ANY SIMILAR COMPLAINT REPORT RECEIVED ON OTHER THD LIGHTSCOPE PROCTO HRA BATCHES OR, MORE EXTENSIVELY, ON OTHER NON-STERILE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES THAT USES THE SAME PACKAGING AND MANUFACTURING PROCESS. SINCE COMPLAINT ANALYSIS AND TECHNICAL INVESTIGATION PERFORMED BY THD SPA, THD AMERICA AND SPAIN DISTRIBUTOR DID NOT REVEAL OTHER SIMILAR ISSUES, AND CONSIDERED THAT IS THE FIRST TIME THAT THD RECEIVE A SIMILAR COMPLAINT ON OVER 30.000 PIECES OF NON STERILE THD LIGHTSCOPE PROCTO HRA MANUFACTURED AND SOLD FROM 2018 TO DATE (OCCURRENCE RATE THAT IS LESS THAN < 10-4) IT IS CLEAR THAT THE PROBLEM IS A PROBLEM SPECIFIC OF THE PRODUCT AT (B)(6) HOSPITAL. THIS CONSIDERATION IS ALSO CONFIRMED IF WE CONSIDER THAT THE SAME PACKAGING (SAME MATERIAL AND WELDING) AND THE SAME MANUFACTURING PROCESS IS USED FOR ALL THD NON-STERILE PRODUCTS OF WHICH IN THE LAST 5 YEARS HAVE BEEN SOLD MORE THAN 500.000 PCS. ALSO CONSIDERING THIS POPULATION OF THESE NON-STERILE PRODUCTS ALREADY IN THE MARKET FOR WHICH NEVER HAPPENED A SIMILAR EVENT OF PACKAGING BREAKAGE, IT IS POSSIBLE STATES THAT THE REOCCURRENCE RATE OF THIS PROBLEM RESULTS TO BE EVEN LOWER 2*10-6. WE ALSO EMPHASIZE THAT THE DEVICE THD LIGHTSCOPE PROCTO HRA, DESPITE SOLD AS NON STERILE PRODUCT, IS ASSEMBLED IN A CONTROLLED ENVIRONMENT, WITH PROCESSES AND MANUFACTURING MEASURES AND CONTROLS SIMILAR TO THE STERILE PRODUCT AND THAT THE PACKAGING CONSISTS OF THREE DIFFERENT LEVEL OF PROTECTION: PRIMARY PACKAGING WITH HEAT-SEALED ENVELOPE. SECONDARY PACKAGING WITH CARTON BOX. PALLET WITH MULTIPLE CARTON BOX SEALED WITH PROTECTIVE FILM TO PACK THE PALLET. BASED ON ALL THESE CONSIDERATIONS IT'S CLEAR THAT THE REPORTED EVENT IS A RARE AND ISOLATED EVENT NOT CAUSED BY PROBLEM IN THE MANUFACTURING PROCESS BECAUSE THERE ARE NO ELEMENTS TO HYPOTHESIZE THAT THE PROBLEM AROSE IN PRODUCTION BUT SURELY OCCURRED AFTER THE RELEASE OF THE PRODUCT FOLLOWING THE DAMAGE TO THE PACKAGE CAUSED BY TRANSPORT, PROBABLY BETWEEN THD SPA AND CUSTOMER, OR DUE TO STORAGE OR MANIPULATION AT MOUNT SINAI HOSPITAL IN IMPROPER CONDITIONS. MOREOVER ON THD LIGHTSCOPE PROCTO HRA LABELLING (BOTH LABELS ON PRIMARY AND SECONDARY PACKAGING AND ON RELEVANT USER MANUAL), EXACTELY AS REPORTED ON ALL THD STERILE DEVICES LABELLING, IT IS REPORTED TO "DO NOT USE IF THE PACKAGE IS BROKEN OR DAMAGED"; THEREFORE THE DEVICE, IN CASE OF BROKEN OR DAMAGED PACK, MUST NOT BE USED PRECISELY BECAUSE DAMAGE TO THE PACKAGING IS ALWAYS A CASE THAT CAN HAPPEN. FROM THE IMAGES RECEIVED IT IS CLEAR THAT THE PACKAGING IS DAMAGED AND THEREFORE THE PRODUCT SHOULD NOT HAVE BEEN USED, IF THE CUSTOMER / USER HAD FOLLOWED INSTRUCTIONS FOR USE OF THE PRODUCT. IN CONCLUSION THE PENETRATION OF INSECTS IS EVIDENTLY DUE TO THE BREAKAGE OF THE ENVELOPE WHICH PROBABLY OCCURRED DURING TRANSPORT AND/OR STORAGE/MANIPULATION AND THERE ARE NO ELEMENTS TO HYPOTHESIZE THAT THE PROBLEM AROSE IN PRODUCTION SINCE THD LIGHTSCOPE PROCTO HRA ARE MANUFACTURED IN A CONTROLLED ENVIRONMENT AND RELEVANT ENVIRONMENTAL PERIODIC CONTROLS (I.E. BIOBURDEN LEVELS) PERFORMED ON INVOLVED DEVICE AND ON OTHER DEVICES MANUFACTURED AND PACKAGED IN THE SAME MANNER, DID NOT HIGHLIGHT ANY ANOMALIES. IF THE INVOLVED DEVICES HAVE BEEN USED CORRECTLY BY CHECKING THE INTEGRITY OF THE PACK, AS REQUIRED BY THE LABELLING, THE RISK FOR THE PATIENT DOES NOT EXIST AS IT IS IMPOSSIBLE, FROM THE EVIDENCE GATHERED, THAT THE PRODUCT IS CONTAMINATED. IF, OTHERWISE, THE PRIMARY PACK WAS BROKEN, THERE WAS AN INCORRECT USE AS THE PRODUCT WAS USED ANYWAY, IN A WAY DIFFERENT FROM THE PRESCRIPTIONS AND THIS REGARDLESS OF THE PRESENCE OF FOREIGN BODIES. THE MONITORING ACTIVITY ON NEW DEVICES IS CARRIED OUT ROUTINELY. SHOULD WE GET FURTHER INFORMATION, ADDITIONAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

DURING THE PREPARATION OF AN HIGH RESOLUTION ANOSCOPY (HRA) EXAM, THE MEDICAL ASSISTANT, OPENING THE PACKAGE OF THE LIGHTSCOPE PROCTO HRA ANOSCOPE (NOT STERILE), NOTICED A FOREIGN BODY OUT OF THE SCOPE ON THE OBTURATOR. AT CLOSER OBSERVATION THIS WAS AN INSECT OR LARVA FROM AN INSECT. THD LIGHTSCOPE PROCTO HRA ANOSCOPES FROM A DIFFERENT LOT NUMBER WERE USED TO COMPLETE THE EXAMS.