Description of Event or Problem · 0
ON BEHALF OF KARL STORZ ENDOSCOPY-AMERICA, INC., I¿M WRITING TO PROVIDE CLARIFICATION ON AN INCIDENT THAT OCCURRED ON (B)(6) 2024, WHICH INVOLVED A MALFUNCTION FROM A HAND INSTRUMENT THAT BURNED THE SURFACE OF A PATIENT¿S SKIN DURING A PROCEDURE (REF.976988). UPON FURTHER INVESTIGATION, OUR TEAM DETERMINED THAT THE PRODUCT IN QUESTION THAT CAUSED AN ADVERSE EVENT WAS NOT MANUFACTURED NOR DESIGNED BY KARL STORZ ENDOSCOPY. THE ALLEGED PRODUCT WAS A SNOWDEN PENCER 89-4000. AS A RESULT, OUR TEAM IS NOT REQUIRED TO SUBMIT AN MDR. HOWEVER, I WOULD LIKE TO ACKNOWLEDGE THAT A KARL STORZ-LAP UROLOGY TRAY (KSZ-27717DS), WAS USED WHEN THE USER FACILITY STERILIZED THE NON-KARL STORZ INSTRUMENT THAT WAS INVOLVED IN THE INCIDENT. THE KARL STORZ TRAY DID NOT CONTRIBUTE TO NOR CAUSE THE MALFUNCTION AND SERIOUS INJURY. WE REMAIN DEDICATED TO PATIENT SAFETY AND REGULATORY COMPLIANCE. PLEASE LET ME KNOW IF THERE IS ANYTHING I CAN DO TO PROVIDE MORE CLARITY ON THIS INCIDENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).