STORZ MONOPOLAR NEEDLE

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED. IT WAS REPORTED THAT DURING PROCEDURE, SPARKING OCCURRED AT A MONOPOLAR NEEDLE FROM A COMPETITOR. NO PATIENT INJURY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).