POWER STICK M4

Additional Manufacturer Narrative

THERE ARE NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS; IN GENERAL, NO SIGNIFICANT DETAILS REGARDING THE INCIDENT WERE PROVIDED. HOWEVER, AN MDR REVIEW OF THE PAST TWO YEARS REVEALED EARLIER REPORTS OF A SIMILAR PROBLEM THAT WERE CLASSIFIED AS REPORTABLE EVENTS CONSTITUTING SERIOUS INJURY. BASED ON THIS SITUATION RICHARD WOLF GMBH CONSIDER REPORTING THIS CASE AS REPORTABLE MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT THE HANDPIECE HAS FAILED TO MORCELLATE DURING A PATIENT PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. THERE WAS NO REPORTED DELAY IN THE PROCEDURE AND NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED. THERE WAS A SIMILAR BACK UP INSTRUMENT AVAILABLE AND THE SCHEDULED PROCEDURE WAS COMPLETED.