Alexis Wound Protector-Retractor C8302Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915117214), received between Mar 4, 2017 and Jun 6, 2019 — classified as 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Material Separation; Material Separation

  NAME OF PROCEDURE BEING PERFORMED: HYSTEROMYOTOMY (OPEN), PAPILLOTOMY DETAILED DESCRIPTION OF EVENT: "HOSPITAL: (B)(6) HOSPITAL. SURGEON: PROF. (B)(6). DEPARTMENT: OB/GYN. SURGERY: HYSTEROMYOTOMY (OPEN). PRODUCT USED: ALEXIS (M). DATE OF SURGERY: (B)(6) 2019. HOSPITAL CALLED THE SALES MANAGER OF OUR DISTRIBUTOR ON (B)(6) 2019 AND INFORMED THAT AT THE END OF THE CASE, THEY NOTICED THE ALEXIS TORN (BOTTOM PART-GREEN RING SIDE) HOSPITAL THROW AWAY THE UNIT ON FRIDAY LAST WEEK AND DISTRIBUTOR CAN'T COLLECT THE UNIT AS THEY HAD CALL THIS MORNING. QUESTION FROM HOSPITAL. THEY WORRIED IF SOME PARTICLES FROM THE UNIT LEFT INSIDE OF PATIENT BODY. DO WE HAVE ANY REFERENCE OR INCIDENT CAUSED PROBLEM DUE TO THIS TYPE OF INCIDENT." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 15MAY2018 FROM APPLIED MED, FIN AND ADMIN MGR. CER FORM WAS RECEIVED. "AFTER THE PROCEDURE, ALEXIS WAS TEARED AND COULD NOT FIND THE TEARED PART AND CLOSED AND COMPLETED THE PROCEDURE. DEALERS QUESTIONING TO US THAT SHOULD BE OKAY OR NOT." TYPE OF INTERVENTION: "ALEXIS WAS TEARED AND COULD NOT FIND THE TEARED PART AND CLOSED AND COMPLETED THE PROCEDURE." PATIENT STATUS: NO PATIENT INJURY OCCURRED ASSOCIATED WITH THE RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675262 ↗
• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  LAPAROSCOPIC ANTERIOR RESECTION- "ALEXIS RETRACTOR SPLIT AS SOON AS IT WAS DEPLOYED." PATIENT STATUS - UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378853 ↗
• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  LAPAROSCOPIC HEMICOLECTOMY: "WHEN REMOVING ALEX FROM THE PT, THE PLASTIC PART OF THE DEVICE CAME APART FROM THE RING." PATIENT STATUS - UNCHANGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378850 ↗