SHOULDER SUSPENSION TOWER

Additional Manufacturer Narrative

THE SHOULDER SUSPENSION TOWER IS DESIGNED TO POSITION, SUPPORT AND/OR DISTRACT THE PATIENT¿S SHOULDER IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO LATERAL ARTHROSCOPIC AND MINI-OPEN SHOULDER SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. THE CUSTOMER ALLEGED THAT THE SHOULD SUSPENSION TOWER HAD ITS BLUE CORD TIED TO THE UNIT AND SNAPPED OFF DURING THE SURGERY AND THE DOCTOR MANUALLY SUPPORTED THE PATIENT'S ARM. BAXTER HAS CONTACTED THE ACCOUNT THREE TIMES REQUESTING THE DEVICE TO BE RETURNED FOR INSPECTION. THE ACCOUNT WAS UNRESPONSIVE TO THE ATTEMPTS AND THE DEVICE DID NOT RETURN TO MANUFACTURE. THEREFORE, BAXTER IS COMPLETING THIS COMPLAINT DUE TO THE AMOUNT OF TIME. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A BLUE CORD SNAPPING OFF WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT DURING A SHOULDER PROCEDURE, A SHOULDER SUSPENSION TOWER HAD ITS BLUE CORD TIED TO THE UNIT AND SNAPPED OFF DURING THE SURGERY. THE PATIENT WAS UNINJURED, AND THE PROCEDURE WAS FINISHED WITHOUT INCIDENT. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.