Alexis Wound Protector-Retractor C8312Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915117245), received between Mar 4, 2017 and Feb 13, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC MYOMECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4), COMPLAINT 2 OF 2: (B)(4). DURING THE SURGERY, A GAS LEAKAGE ISSUE WAS NOTICED AFTER A PERIOD OF OPERATION. WHEN THE USER REMOVED THE C8312 FOR INSPECTION, IT WAS FOUND THAT THE GREEN RING HAD PARTIALLY DETACHED FROM THE WOUND SHEATH. AFTER REPLACING IT WITH A NEW ONE, THE SAME ISSUE OCCURRED AGAIN AFTER SOME TIME. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20 JAN 2025 VIA EMAIL: THE MALFUNCTION OCCURRED MID-PROCEDURE. IT WAS OBSERVED THAT THE PATIENT'S ABDOMINAL INSUFFLATION HAD DECREASED, LEADING TO THE SUSPICION OF A POTENTIAL AIR LEAKAGE. UPON INVESTIGATION, IT WAS IDENTIFIED THAT THE LEAKAGE ORIGINATED FROM C8312. THE ISSUE WAS CONFIRMED WHEN C8312 WAS REMOVED FROM THE PATIENT, REVEALING THE PROBLEM. THE SHEATH BECAME DETACHED AT THE CONNECTION POINT WITHIN THE GREEN RING. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING PLACEMENT. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING THE PROCEDURE. THE DEVICE DID NOT PARTICULATE. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: THE PATIENT IS IN GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377168 ↗
• MalfunctionFeb 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAPAROSCOPIC MYOMECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4), COMPLAINT 2 OF 2: (B)(4). DURING THE SURGERY, A GAS LEAKAGE ISSUE WAS NOTICED AFTER A PERIOD OF OPERATION. WHEN THE USER REMOVED THE C8312 FOR INSPECTION, IT WAS FOUND THAT THE GREEN RING HAD PARTIALLY DETACHED FROM THE WOUND SHEATH. AFTER REPLACING IT WITH A NEW ONE, THE SAME ISSUE OCCURRED AGAIN AFTER SOME TIME. USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20 JAN 2025 VIA EMAIL: THE MALFUNCTION OCCURRED MID-PROCEDURE. IT WAS OBSERVED THAT THE PATIENT'S ABDOMINAL INSUFFLATION HAD DECREASED, LEADING TO THE SUSPICION OF A POTENTIAL AIR LEAKAGE. UPON INVESTIGATION, IT WAS IDENTIFIED THAT THE LEAKAGE ORIGINATED FROM C8312. THE ISSUE WAS CONFIRMED WHEN C8312 WAS REMOVED FROM THE PATIENT, REVEALING THE PROBLEM. THE SHEATH BECAME DETACHED AT THE CONNECTION POINT WITHIN THE GREEN RING. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING PLACEMENT. NO INSTRUMENTS WERE USED WITHIN THE ALEXIS DURING THE PROCEDURE. THE DEVICE DID NOT PARTICULATE. INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: THE PATIENT IS IN GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376855 ↗
• MalfunctionJun 23, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED: CS - "THE SURGEON INSERTS THE GREEN RING TO PATIENT BODY, AND THEN THEY STARTING TO CURL THE WHITE RING WITH WOUND SHEATH. SUDDENLY, THE WOUND SHEATH JUST CAME APART NEAR GREEN RING." TYPE OF INTERVENTION: NO INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. PATIENT STATUS: "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664655 ↗
• MalfunctionApr 4, 2017Material Perforation; Material Perforation

  VATS - "THIS DEVICE INSERTS THE GREEN RING TO PATIENT BODY. WHEN THEY CURLING THE WHITE RING AND FIND OUT THE SHEATH IS SEPARATED WITH GREEN RING. TWO OF C8312 WERE USED IN TWO SURGERIES ON SAME DAY. ONE OF C8312 WAS ABANDONED BY CLIENT." TYPE OF INTERVENTION - NA. PATIENT STATUS - "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6457153 ↗
• MalfunctionApr 4, 2017Material Perforation; Material Perforation

  VATS - "THIS DEVICE INSERTS THE GREEN RING TO PATIENT BODY. WHEN THEY CURLING THE WHITE RING AND FIND OUT THE SHEATH IS SEPARATED WITH GREEN RING. PLEASE CONSULT WITH ATTACHED PHOTO. TWO OF C8312 WERE USED IN TWO SURGERIES ON SAME DAY. ONE OF C8312 WAS ABANDONED BY CLIENT." PATIENT STATUS - "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6457098 ↗
• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  APPENDECTOMY- "CLIENT JUST SET UP THIS DEVICE AND THEN FOUND THE PROTECTOR WAS BROKEN. " PATIENT STATUS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378870 ↗
• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED UNKNOWN - "THE PROTECTOR WAS BROKEN." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378854 ↗