ALEXIS LAPAROSCOPIC SYSTEM

Additional Manufacturer Narrative

NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN PROVIDED TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

Description of Event or Problem

PROCEDURE PERFORMED: ROBOT-ASSISTED LOW ANTERIOR RESECTION EVENT DESCRIPTION: THIS IS A CER WHICH CAME FROM FEEDBACK. HOSPITAL [NAME]. COMPLAINT; WHAT HAPPENED. IN EARLY (B)(6) 2025, A PROBLEM HAPPENED DURING A ROBOT-ASSISTED LOW ANTERIOR RESECTION AT [FACILITY] (GASTROINTESTINAL SURGERY). THE SURGEON USED C8501 AS THE CAMERA PORT OF [ROBOT]. DURING THE OPERATION, A CLIP APPLIER INSERTED FROM ANOTHER PORT GOT CAUGHT ON THE TETHER CORD OF C8501. THE CORD WAS ENTANGLED WITH THE IMA (INFERIOR MESENTERIC ARTERY). THIS HAPPENED OUTSIDE THE CAMERA VIEW, SO IT WAS VERY DANGEROUS. THE SURGEON, DR. [NAME], SAID THERE MIGHT HAVE BEEN SLACK IN THE CORD INSIDE THE ABDOMEN. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20AUG2025: THE [ROBOT] PORT SETUP WAS: PORT 1: ASSIST PORT (RIGHT) PORT 2: CAMERA PORT 3: SURGEON¿S LEFT HAND PORT 4: SURGEON¿S RIGHT HAND THREE ARMS WERE USED. THE CLIP APPLIER WAS INSERTED FROM PORT 1 (ASSIST PORT), WHICH IS LOCATED TO THE RIGHT OF THE CAMERA PORT (PORT 2). THE SURGEON PLACED THE ALEXIS LAPAROSCOPIC SYSTEM (C8501). NOTE: THE CAP WAS NOT USED. THE TETHER WAS KEPT OUTSIDE THE PATIENT. WE COULD NOT CONFIRM WHETHER THE SURGEON SWEEPED THE INNER RING AFTER DEPLOYING THE ALEXIS. BASED ON THE FACT THAT THE TETHER WAS LOOSE, WE ASSUME THE INNER RING WAS LIKELY NOT SWEPT THE ISSUE HAPPENED OUTSIDE OF THE SURGICAL FIELD AND WAS NOT VISIBLE. THE TETHER WAS ACCIDENTALLY CAUGHT BY THE CLIP APPLIER DURING INSERTION, AND IT GOT TANGLED WITH THE IMA (INFERIOR MESENTERIC ARTERY). YES, IT HAPPENED OUTSIDE THE VISIBLE CAMERA FIELD. THE SURGEON AND THE ASSISTANT WORKED TOGETHER TO REMOVE THE TETHER FROM THE CLIP APPLIER AND IMA. YES, THE SURGEON CONTINUED USING THE SAME LAPAROSCOPIC SYSTEM (C8501) AFTER RESOLVING THE ISSUE. INTERVENTION: KEPT USING THE EVENT UNIT AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

Description of Event or Problem

PROCEDURE PERFORMED: ROBOT-ASSISTED LOW ANTERIOR RESECTION. EVENT DESCRIPTION: THIS IS A CER WHICH CAME FROM FEEDBACK. HOSPITAL [NAME]. COMPLAINT; WHAT HAPPENED. IN EARLY (B)(6) 2025, A PROBLEM HAPPENED DURING A ROBOT-ASSISTED LOW ANTERIOR RESECTION AT [FACILITY] (GASTROINTESTINAL SURGERY). THE SURGEON USED C8501 AS THE CAMERA PORT OF [ROBOT]. DURING THE OPERATION, A CLIP APPLIER INSERTED FROM ANOTHER PORT GOT CAUGHT ON THE TETHER CORD OF C8501. THE CORD WAS ENTANGLED WITH THE IMA (INFERIOR MESENTERIC ARTERY). THIS HAPPENED OUTSIDE THE CAMERA VIEW, SO IT WAS VERY DANGEROUS. THE SURGEON, DR.[NAME], SAID THERE MIGHT HAVE BEEN SLACK IN THE CORD INSIDE THE ABDOMEN. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON (B)(6) 2025: THE [ROBOT] PORT SETUP WAS: PORT 1: ASSIST PORT (RIGHT). PORT 2: CAMERA PORT. PORT 3: SURGEON¿S LEFT HAND. PORT 4: SURGEON¿S RIGHT HAND. THREE ARMS WERE USED. THE CLIP APPLIER WAS INSERTED FROM PORT 1 (ASSIST PORT), WHICH IS LOCATED TO THE RIGHT OF THE CAMERA PORT (PORT 2). THE SURGEON PLACED THE ALEXIS LAPAROSCOPIC SYSTEM (C8501). NOTE: THE CAP WAS NOT USED. THE TETHER WAS KEPT OUTSIDE THE PATIENT. WE COULD NOT CONFIRM WHETHER THE SURGEON SWEEPED THE INNER RING AFTER DEPLOYING THE ALEXIS. BASED ON THE FACT THAT THE TETHER WAS LOOSE, WE ASSUME THE INNER RING WAS LIKELY NOT SWEPT THE ISSUE HAPPENED OUTSIDE OF THE SURGICAL FIELD AND WAS NOT VISIBLE. THE TETHER WAS ACCIDENTALLY CAUGHT BY THE CLIP APPLIER DURING INSERTION, AND IT GOT TANGLED WITH THE IMA (INFERIOR MESENTERIC ARTERY). YES, IT HAPPENED OUTSIDE THE VISIBLE CAMERA FIELD. THE SURGEON AND THE ASSISTANT WORKED TOGETHER TO REMOVE THE TETHER FROM THE CLIP APPLIER AND IMA. YES, THE SURGEON CONTINUED USING THE SAME LAPAROSCOPIC SYSTEM (C8501) AFTER RESOLVING THE ISSUE. INTERVENTION: KEPT USING THE EVENT UNIT AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, A VIDEO OF THE EVENT WAS PROVIDED. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF THE ALEXIS TETHER CORD CAUGHT IN THE CLIP APPLIED TO THE PATIENT¿S ARTERY. A CLEAR FRAGMENT WITH ROUGH EDGES RESEMBLING THE SHEATH WAS ALSO OBSERVED IN THE VIDEO BASED ON THE INFORMATION PROVIDED BY THE MEDICAL SUBJECT MATTER EXPERT, A SURGEON WHO IS FAMILIAR WITH THE DEVICE, THE INCIDENT WAS MOST LIKELY THE RESULT OF USER ERROR, AS THE TETHER CORD WAS CLEARLY VISIBLE WITHIN THE CLIP APPLIER JAWS PRIOR TO CLIP PLACEMENT. THIS CAUSED THE CORD TO BE CAUGHT IN THE CLIP WHEN IT IS SECURED ON THE PATIENT'S ARTERY, RESULTING IN TENSION ON THE ARTERY. IT IS ALSO POSSIBLE THAT THE CLIP APPLIER PERFORATED THE SHEATH AND PICKED UP THE CORD PRIOR TO THE FIRST CLIP PLACEMENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED. THE PROBABILITY AND CRITICALITY OF THE HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.