CYSTOSCOPE 15FR X 37MM ADULT

Additional Manufacturer Narrative

PRODUCT WAS NOT RETURNED THEREFORE; NO EVALUATION OR TESTING FOR COMPLAINT ISSUE COULD BE COMPLETED.

Description of Event or Problem

ALLEGEDLY PER THE CUSTOMER, REPORTS OF BACTERIAL INFECTIONS OCCURRED POST-OPERATIVE ON SEVERAL OCCASIONS DURING THE MONTHS OF (B)(6) 2020.

Additional Manufacturer Narrative

THE ENDOSCOPE WAS SAMPLED TO DETERMINE IF CONTAMINATION WAS PRESENT IN THE CHANNEL WHEN RETURNED FROM THE CUSTOMER. THE RESULTS OF THE SAMPLE IDENTIFIED THREE MICROORGANISMS, WHERE ONLY ONE OF WHICH, CHRYSEOBACTERIUM, IS POTENTIALLY CONSIDERED OF HIGH CONCERN BASED ON MORPHOLOGY(I.E. GRAM NEGATIVE, ROD). EACH MOCROORGANISM GREW IN LOW NUMBERS WITH 1 COLONY FORMING UNIT(CFU) BEING RECORDED PER ISOLATE. IT COULD NOT BE CONFIRMED WHETHER THE ORGANISMS IDENTIFIED MATCH THOSE LINKED TO PATIENT INFECTIONS AS THIS INFORMATION WAS NOT PROVIDED. THE ORGANISMS OF LOW CONCERN, MICROCOCCUS LUTEUS AND DERMACOCCUS NISHINOMIYAENSIS, MOST LIKELY RESULTED FROM AN EXTERNAL SOURCE OF CONTAMINATION(E.G. LABORATORY SAMPLING)BASED ON THEIR TYPICAL ENVIRONMENTAL SOURCE (E.G. HUMAN SKIN). ALTHOUGH LABORATORY TESTS PERFORMED ON THE RETURNED PRODUCTS IDENTIFIED A SINGLE HIGH CONCERN ORGANISM FOLLOWING RETURN TO KARL STORZ, NO MICROBIOLOGICAL CONTAMINATION WERE IDENTIFIED AFTER STANDARD REPROCESSING. THIS INDICATES THAT THERE MAY BE GAPS IN THE EXISTING REPOCESSING METHODS BY THE CUSTOMER. STANDARD REPROCESSING AS PERFORMED IN THE EVALUATION CENTER AT KSE-CHARLTON RESOLVED THE CONTAMINATION AND INDICATES THAT NO MAJOR CONTAMINATION ISSUES/BIOFIL FORMATION IS PRESENT. COMPLIANCE WITH THE STANDARD, VALIDATED PROCEDURE FOR REPROCESSING OF KARL STORZ FLEXIBLE ENDOSCOPES ENSURES PATIENT SAFETY. BASED ON THIS INVESTIGATION, THIS SCOPE PASSED ALL OUTGOING INSPECTION REQUIREMENT AND THE DEVICE HISTORY RECORD DID NOT CONTAIN ANY ANOMALIES THAT WOULD CONTRIBUTE TO THE FAILURE IN THE FIELD. THE IFU HAS STATEMENTS REGARDING PROPER DISINFECTION AND STERILIZATION OF THE DEVICE PRIOR TO USE.

Description of Event or Problem

COMPLAINT ID: (B)(4).