GEM FLOW COUPLER

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. DURING REVIEW OF THE PHOTO PROVIDED OF THE 3.0MM FLOW COUPLER PRODUCT, NO DAMAGE TO ANY PORTION OF THE FLOW COUPLER PRODUCT (JAW/PROBE ASSEMBLY) WAS NOTED. ADDITIONALLY, THERE WERE NO SIGNS OF USE PRESENT WHICH IS CONSISTENT WITH THE COMPLAINANT¿S STATEMENT THAT THE ALLEGED EVENT OCCURRED PRIOR TO USE. THE USER WOULD LIKELY DETECT THIS ISSUE DURING PRODUCT SET-UP PRIOR TO PATIENT USE. THE USER WOULD ALSO HAVE THE OPTION TO USE A NEW DEVICE. AFTER CONSIDERATION FOR POTENTIAL HARMS AND WORST-CASE SCENARIOS, THERE WOULD BE NO ADVERSE HEALTH CONSEQUENCE REASONABLY EXPECTED TO RESULT FROM THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A FLOWCOUPLER PROBE CABLE WAS NOT CONNECTED AND THE RING DISCONNECTED DURING CONDITIONING. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP DURING AN UNSPECIFIED SURGERY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.