STRYKER SERFAS ENERGY 90-S, 90 DEGREE SUCTION PROBE, W/INTEGRATED CORD, (GREY) 3

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPY, THE REPROCESSED SERFAS WAND'S TIP BROKE OFF INTO THE PATIENT'S SHOULDER. PER REPORT, THE WAND BECAME HOT, A PIECE OF THE TIP BUBBLED AND THEN THE TIP FLAKED OFF INTO THE PATIENT'S SHOULDER. THE PHYSICIAN WAS REPORTEDLY ABLE TO LOCATE THE BROKEN PIECE AND SUCCESSFULLY RETRIEVE IT FROM THE PATIENT. THERE WAS NO SERIOUS INJURY REPORTED RELATED TO THE EVENT. IT WAS REPORTED THAT THE FACILITY WAS ABLE TO GRAB ANOTHER DEVICE AND THE SURGERY COMMENCED WITHOUT FURTHER INCIDENT. THE REPROCESSED DEVICE WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. DUE TO REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE REPROCESSED SERFAS WAND'S TIP BROKE OFF INTO THE PATIENT'S SHOULDER.

Additional Manufacturer Narrative

THE REPORTING FACILITY RETURNED ON (B)(6) 2018 THE DEVICE INVOLVED IN THE REPORTED INCIDENT. THE REPORTED EVENT THAT THE TIP HAD BROKEN OFF OF THE PROBE WAS CONFIRMED. IT WAS CONFIRMED THAT THE DEVICE WAS REPROCESSED BY MEDLINE RENEWAL. A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED AND INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED. A ROOT CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.