UNIVERSAL CABLE

Description of Event or Problem

THE CUSTOMER REPORTED THAT THIS CABLE WAS IN USE WITH A SAGITTAL SAW THAT FAILED TO OPERATE PROPERLY, AND RESULTED IN AN APPROXIMATE 90 MINUTE SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE DEVICE. THERE WAS NO REPORTED INJURY AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS DEVICE FOR EVAL ON 04/22/2008. THE RETURNED UNIVERSAL CABLE USED WITH THE MICROPOWER SAGITTAL SAW WAS EVALUATED. THE EVALUATOR FOUND SEVERAL CONNECTOR PINS DAMAGED (BENT AND/OR PUSHED IN) AT THE CONSOLE CONNECTOR END, WHICH CAUSED THE HANDPIECE TO PERFORM IMPROPERLY. THE USER MANUAL INFORMS THE CUSTOMER OF THE FOLLOWING: DO NOT HANDLE THE HANDPIECES BY THE CORD. DO NOT PULL ON THE CORD TO REMOVE IT FROM THE HANDPIECE CONTROLLER. USE THE CONNECTOR PORTION OF THE CORD FOR DISCONNECTION. DO NOT EXCESSIVELY BEND OR KINK THE HANDPIECE CORD. ALWAYS INSPECT CORDS FOR SIGNS OF EXCESSIVE WEAR OR DAMAGE. IF WEAR OR DAMAGE IS FOUND, DISCONTINUE USE AND REPLACE IMMEDIATELY. AN EVAL OF THE SAW WAS UNABLE TO CONFIRM THE REPORTED PROBLEM. DURING TESTING OF THIS HANDPIECE, IT FUNCTIONED PROPERLY. FURTHER INVESTIGATION FOUND THAT THE UNIT FAILED GROUND BOND TESTING, AND A VISUAL EXAMINATION FOUND THE CAST STATOR PEELING AND THE ROTOR ASSEMBLY WITH MINOR RUST-LIKE DEPOSITS FROM MOISTURE INTRUSION. NEITHER OF THESE FINDINGS AFFECTED THE FUNCTIONALITY OF THE DEVICE. ASSOCIATED MDR: 1017294-2008-00178.