Alexis ® O C-Section Protector - Retractor G6314Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915118136), received between Feb 26, 2016 and Mar 4, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2017Material Perforation; Material Perforation

  C-SECTION - "AFTER THE PROCEDURE THE SURGEON RECOGNIZED THAT THE FILM OF THE ALEXIS RETRACTOR WAS DETACHED FROM THE INNER RING. THERE WAS NO KNIFE OR SCISSORS USED." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6378862 ↗
• MalfunctionFeb 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CASEREAN SECTION - "A BABY BOY WAS CUT ON THE BUTTOCKS DURING A CASEREAN SECTION AT (B)(6) ON (B)(6) 2016. THE SURGEON BELIEVES THAT THE CUTS WERE CAUSED BY THE ALEXIS O C-SECTION RETRACTOR. THE BABY WAS 11LBS 2OZ. AND WAS BREACHED SO THEY STRUGGLED TO GET HIM OUT. THE SCRUB TECH AND THE CIRCULATING NURSE BOTH STATED THAT THERE WERE NO OTHER INSTRUMENTS USED AFTER THE INCISION WAS MADE TO THE UTERUS. THEY DID NOT KEEP THE PRODUCT THAT WAS USED IN THE PROCEDURE." PATIENT STATUS - "PATIENT RECEIVED MINOR CUTS THAT WERE NOT LIFE THREATENING."

  Patient problems: Abrasion

  MAUDE report 5464576 ↗