Alexis® Contained Extraction System GTB17Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915134280), received between Mar 17, 2016 and May 6, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Cut In Material” (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 16, 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 6, 2025Material Separation; Material Separation

  PROCEDURE PERFORMED: VNOTES HISTERECTOMY. EVENT DESCRIPTION: THEY WERE TRYING TO OPEN THE BAG INSIDE THE ABDOMEN. THE SURGEON WAS TRYING TO OPEN THE BAG PULLING THE STRAP WITH SNAP FASTENER IN ORDER OPEN THE BAG INSIDE THE ABDOMEN WITH THE GRASPER THE STRAP BROKE. BESIDES ONE THE MANIPULATION TABS ALSO BROKE WHEN THE SURGEON TRIED TO REMOVE THE WHITE RING. THEY MANAGED TO OPEN AND REMOVED THE BAG AND COMPLETE THE MANUAL MORCELATION. WITH NO PROBLEMS. INTERVENTION: THEY MANAGED TO OPEN AND REMOVED THE BAG AND COMPLETE THE MANUAL MORCELATION WITH NO PROBLEMS. PATIENT STATUS: THE PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971962 ↗
• MalfunctionJun 22, 2021Material Rupture; Material Rupture

  NAME OF PROCEDURE BEING PERFORMED. LAPAROSCOPIC HYSTERECTOMY. REP WAS NOT PRESENT FOR THE CASE. WHILE USING ALEXIS CES BAG TO REMOVE A LARGE SPECIMEN, THE BAG BROKE WHILE BEING REMOVED. THE SPECIMEN WAS DELIVERED INSIDE BAG, IT WAS NOTICED AFTER THE BAG WAS REMOVED FROM THE PATIENT THAT THE BAG TORE ON A SEAM AND A SMALL PIECE BROKE OFF WHICH WAS FOUND AND REMOVED. SURGEON BELIEVES THAT THE BAG BROKE UNDER PRESSURE WHILE BEING REMOVED THROUGH THE VAGINA. THE TEAR WAS FOUND AT THE SEAM ON THE CORNER OF THE BAG TOWARDS THE BOTTOM. THE UTERUS WAS BEING REMOVED IN THE BAG. THE TEAR WAS NOTICED UPON PHYSICAL EXAMINATION OF THE BAG ONCE IT WAS REMOVED. IT IS UNKNOWN IF THE SPECIMEN WAS MORCELLATED. THERE WAS NO PATIENT INJURY AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE. PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 08JUN2021 FROM [NAME]: "THE ALEXIS CES BAG WAS INTRODUCED VAGINALLY, LAPAROSCOPIC DEVICES PLACED THE SPECIMEN IN THE BAG. THE BAG¿S WHITE RING WAS THEN EXTERNALIZED. THERE WASN¿T ANY MORCELLATION PERFORMED. THE DOCTOR PULLED THE BAG WITH A LOT OF FORCE, THE BAG BROKE AND CAME OUT WITHOUT THE SPECIMEN, BUT THE SPECIMEN HAD BEEN ADVANCED INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041222 ↗
• MalfunctionFeb 7, 2017Material Perforation; Material Perforation

  ROBOTIC LEFT LAPAROSCOPIC RADICAL NEPHRECTOMY - THE DOCTOR MADE AN INCISION AND PLACED THE BAG INSIDE THE PATIENT, THE SPECIMEN WAS PLACED IN THE BAG AND THE DOCTOR ATTEMPTED TO REMOVE THE SPECIMEN WITHOUT MANUALLY MORCELLATING. THE DISTAL TIP OF THE BAG TORE, THE TEAR WAS APPROXIMATELY 3-4CM. THE TISSUE WAS BELIEVED TO BE CANCEROUS. THE GUARD WAS NOT USED. THE GEL POINT MINI WAS NOT USED, ONLY THE GTB17. TYPE OF INTERVENTION - THE DOCTOR WAS ABLE TO SAFELY REMOVED THE BAG AND THE REMAINS OF SPECIMEN PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309482 ↗
• InjuryMar 17, 2016Cut In Material; Adverse Event Without Identified Device or Use Problem; Cut In Material; Adverse Event Without Identified Device or Use Problem

  TOTAL LAP HYSTERECTOMY - "BAG WAS USED UMBILICAL, SHIELD WAS PLACED. DURING MORCELLATION, THE SURGEON NOTICED DAMAGE TO THE BAG. UNKNOWN IF CAUSED BY CLAMPING OR BY A DIRECT CUT BY A SCALPEL. CUT WAS SEVERAL CM LONG, BELOWSIDE THE SHIELD. " TYPE OF INTERVENTION: RE-OPERATED ON (B)(6) 2016. PATIENT STATUS OK. DOING BETTER (B)(6) 2016.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 5509323 ↗