COUPLER AC ZOOM CHINA LOCAL

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY PROCEDURE IT WAS OBSERVED THAT THE IMAGES OF 2X COUPLER AC ZOOM CHINA LOCAL DEVICES WERE BLURRY, AND UNABLE TO FOCUS THROUGHOUT THE ENTIRE FIELD OF VIEW. ANOTHER DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS EVENT 2 OF 2 OF (B)(4).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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 REPORT, A FOLLOW-UP REPORT 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.