Alexis Laparoscopic System With Kii Fios First Entry C8702Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915125721), received between Jan 11, 2018 and May 25, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE BEING PERFORMED: LEFT ANTERIOR RESECTION DETAILED DESCRIPTION OF EVENT: DR [NAME] WAS USING THE DEVICE TOWARDS THE END OF THE PROCEDURE. INSERTION WAS FINE, THE DEVICE WAS UTILISED FOR REATTACHMENT. THE CAP PUT BACK ON. TOWARDS THE END OF THE PROCEDURE WHEN THE DEVICE WAS BEING USED FOR VISUALISATION DR [NAME] NOTICED THE RIP IN THE PLASTIC. HE WAS CONCERNED THAT IT HAD TORN OFF IN THE PATIENT. HE WAS PULLING THE DEVICE UP STRONGLY WHEN IN USE. ADDITIONAL PHOTOS AVAILABLE IN ATTACHMENTS. PATIENT STATUS: PATIENT IS UNAFFECTED - SURGERY COMPLETE. TYPE OF INTERVENTION: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881955 ↗
• MalfunctionFeb 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  DETAILED DESCRIPTION OF EVENT: "EVENT: DURING THE SURGICAL PROCEDURE AFTER PLACEMENT OF THE ALEXIS IN THE ABDOMEN WITH ITS CAP, WE REALIZED THAT THERE WAS A CO2 LEAK. THE CAP IS REMOVED AND IT IS OBSERVED THAT THE SEPARATING ALEXIS HAS BROKEN, SO THAT THE CO2 ESCAPES THROUGH THE ABDOMEN." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25FEB2021 FROM [NAME]: "THE DAMAGE WAS NOTED ON THE BODY OF THE ALEXIS (PHOTO ATTACHED)" IT IS UNKNOWN IF ANY INSTRUMENTS WERE USED WITHIN THE ALEXIS. THE CASE WAS COMPLETED BY USING "ANOTHER DEVICE WITH THE SAME REFERENCE." A PHOTO HAS BEEN PROVIDED. PATIENT STATUS: "NO HARM TO PATIENT WAS REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11340269 ↗
• MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP COLON.EVENT DESCRIPTION:TRANSPARANT SEAL CAME OF AND FELL INTO PATIENT.PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11247795 ↗
• MalfunctionJan 11, 2018Material Perforation; Material Perforation

  PROCEDURE PERFORMED: LAPAROSCOPIC ANTERIOR BOWEL RESECTION. THE SURGEON ATTEMPTED TO EXTRACT THE ALEXIS RETRACTOR FROM THE PATIENTS ABDOMEN. AND THE MID DRAPING SHEET TEARED OFF AND SLIPPED OFF INSIDE THE ABDOMEN. SURGEON HAS COMPLAINED THAT TEARING OF THE SHEATH SHOULD NOT HAVE HAPPENED PATIENT STATUS: N/A.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7184706 ↗