EPIX LAPAROSCOPIC GRASPER

Additional Manufacturer Narrative

THE EVENT UNIT IS NOT BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

PROCEDURE PERFORMED: NISSEN FUNDOPLICATION. EVENT DESCRIPTION: THE DEVICE WAS USED FOR GRASPING THE STOMACH DURING THE STOMACH MOBILIZATION. AS SOON AS THE DEVICE GRASPED THE STOMACH THERE WAS INJURY AND BLEEDING OF THE STOMACH WHICH WAS CAUSED, ACCORDING TO THE SURGEON'S OPINION, BY THE TRAUMATIC LATIS PADS. THERE WAS NOT ANY CLINICAL IMPACT TO THE PATIENT OTHER THAN BLEEDING, WHICH WAS IMMEDIATELY CONTROLLED BY THE SURGEON, BY STITCHING THE TRAUMA. A DEVICE OF ANOTHER MANUFACTURER WAS USED TO CONTINUE THE SURGICAL OPERATION. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20FEB26: THE CORRECT LOT NR. IS 1563295. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27FEB26: THE BLEEDING OF THE STOMACH LINING OCCURRED AS A RESULT OF USING THE FORCEPS ON THE STOMACH. THEY STITCHED UP THE STOMACH AND CONTINUED THE SURGERY. THE PATIENT¿S CONDITION IS FINE. NO OTHER PRODUCT WAS INVOLVED. THE INCIDENT OCCURRED IMMEDIATELY AFTER THE FORCEPS GRASPED THE STOMACH WALL. RIPS, TEARS OR FRAYS WEREN'T OBSERVED ON THE PAD BEFORE GRASPING. INTERVENTION: A DEVICE OF ANOTHER MANUFACTURER WAS USED TO CONTINUE THE SURGICAL OPERATION PATIENT STATUS: THE PATIENT¿S CONDITION IS FINE. THERE WAS INJURY AND BLEEDING OF THE STOMACH. THERE WAS NOT ANY CLINICAL IMPACT TO THE PATIENT OTHER THAN BLEEDING, WHICH WAS IMMEDIATELY CONTROLLED BY THE SURGEON, BY STITCHING THE TRAUMA.