COUPLER AC FFL 19

Description of Event or Problem

THIS IS REPORT 1 OF 2 OF PC-(B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE FOR A ROTATOR CUFF TEAR WHILE USING THE COUPLER AC DEVICE AND THE HD EPSCP,4.0,30,167,MITEK, THE SURGEON COMPLAINED THAT THE FOCUS WAS SLIGHTLY OFF AND IT WAS DIFFICULT TO GET IT RIGHT, OR THAT THE FOCUS SHIFTED EVERY TIME HE SWITCHED THE CAMERA TO A DIFFERENT PORTAL. AFTER THE SURGERY, THE SALES REP CHECKED THE FOCUS RING OF THE COUPLER. WHEN THE SALES REP HELD THE CAMERA HEAD IN HIS HAND AND TURNED THE FOCUS RING AS FAR LEFT AS HE COULD, HE WAS FINALLY ABLE TO GET THE FOCUS RIGHT, BUT IT WAS STILL UNCLEAR WHETHER THE FOCUS WAS PERFECTLY ACCURATE. THE DEVICE STATE WAS WHERE THE FOCUS COULD ONLY BE ADJUSTED WHEN THE FOCUS RING COULD NO LONGER BE TURNED. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.