Description of Event or Problem · 0
ON (B)(6) 2024, THE PATIENT WAS ADMITTED FOR A HEMICOLECTOMY FOR ADENOCARCINOMA OF THE CECUM. THE SUCTION DEVICE USED DURING THE PROCEDURE WAS A VIA-GUARD STANDARD SUCTION SET MADE BY SURGIMARK, INC. IN (B)(6) OF 2025, A ROUTINE IMAGING WAS PERFORMED WHICH REVEALED A RETAINED FOREIGN BODY LOCATED IN THE LOWER LEFT ABDOMEN. ANOTHER SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2025. AN OUTER SLEEVE FROM THE SUCTION DEVICE WAS REMOVED. THE SLEEVE IS SEPARATED FROM THE MAIN BODY OF THE INSTRUMENT AND ATTACHED WHEN INDICATED. IN THE FIRST SURGERY, THE SLEEVE WAS USED TO PROVIDE ADDITIONAL SUCTION. APPARENTLY WHEN THE DEVICE WAS RE-MOVED FROM THE ABDOMINAL CAVITY, THE SLEEVE WAS NOT COMPLETELY ATTACHED TO THE MAIN BODY OF THE DEVICE AND WAS NOT REMOVED. THERE IS NO NEGATIVE PATIENT OUTCOME. THERE IS A POTENTIAL DESIGN FLAW WHICH ALLOWS THE SLEEVE TO BECOME DETACHED DURING THE PROCEDURE THUS CREATING A POTENTIAL PATIENT SAFETY ISSUE.