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Patient 1
(B)(4). WE RECEIVED A COMPLAINT ABOUT SEVEN PAIRS OF SCISSORS. ACCORDING TO THE CUSTOMER, THE PAIRS OF SCISSORS ARE NO LONGER CUTTING ACCORDING TO THE DESIRED QUALITY. FURTHERMORE, THERE ARE TEN PAIRS OF SCISSORS IN THE HOSPITAL LABELLED WITH BC275R BUT THEY ARE 230MM LONG INSTEAD OF 200MM. ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. ALL PROVIDED PAIRS OF SCISSORS ARE IN USED CONDITION. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. THE DIMENSIONS OF ALL PROVIDED PRODUCTS WERE CHECKED. THE LABELLING OF THE TWO PRODUCTS OF COMPLAINT IS NOT CORRECT. THE SCISSORS ARE 230MM LONG INSTEAD OF 200MM. TUS, THEY SHOULD HAVE BEEN LABELLED WITH THE REF BC277R. ALL OTHER PROVIDED SCISSORS ARE LABELLED CORRECTLY. ACCORDING TO THE Q-COORDINATOR OF THE PRODUCTION PLANT, QUALITY ASSURANCE ANALYZED THE CASE OF MISLABELING SCISSORS BC275R. ORDERS BC275R AND BC277R HAVE BEEN PRODUCED AND RELEASED TO LASER MARKING DEPARTMENT THE SAME DAY. MOST, LIKELY THE EXCHANGE OF DOCUMENTATION DID NOT TAKE PLACE DURING LASER LABELING AND IS TRACEABLE TO AN INDIVIDUAL HUMAN MISTAKE SINCE THE DESIGN OF THE SCISSORS ARE VERY SIMILAR. A FOLLOW UP TRAINING OF ALL INVOLVED PERSON WILL BE INITIATED. FURTHERMORE A CUTTING TEST WAS CARRIED OUT. THE INSUFFICIENT CUTTING PERFORMANCE OF THE CONCERNED PRODUCTS IS MOST LIKELY CAUSED BY WEAR AND TEAR, DUE TO THE AGE AND NUMBER OF APPLICATIONS DURING THIS TIME. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. ONE SIMILAR INCIDENTS (WRONG LABELLING) HAVE BEEN FILED WITH PRODUCTS FROM BATCH 4507560233. NO SIMILAR INCIDENTS (INSUFFICIENT CUTTING) HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE WRONG LABELLING IS MOST PROBABLY RELATED TO A MANUFACTURING ERROR.