Alexis Contained Extraction System with GelPOINT Mini Advanced Access Platform GTM17Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20607915135700), received between Nov 2, 2017 and Nov 2, 2017 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED -TOTAL LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGECTOMY SINGLE OOPHORECTOMY EVENT DESCRIPTION: "[SURGEON] USED THE GTM17 FOR A TOTAL LAPAROSCOPIC HYSTERECTOMY BILATERAL SALPINGECTOMY AND SINGLE OOPHORECTOMY. THE GELPOINT MINI WAS OPENED AT THE START OF THE PROCEDURE. THE XS ALEXIS O WAS INSERTED INTO THE UMBILICUS. THE RING WAS THEN ROLLED INWARDS TO SHORTEN THE SHEATH. THE LARGE TROCAR WAS THEN INSERTED INTO THE CENTRE OF THE GEL CAP. THE CAP WAS THEN PLACED ON THE XS ALEXIS O. THE TOTAL LAPAROSCOPIC HYSTERECTOMY WAS THEN PERFORMED. HALFWAY DURING THE PROCEDURE IT WAS DECIDED THAT A SECOND PORT WAS REQUIRED THROUGH THE GELPOINT MINI. THE CAP WAS REMOVED AND A SECOND PORT WAS INTRODUCED. THE GEL CAP WAS THEN REPLACED AND THE PROCEDURE CONTINUED. AFTER THE COLPOTOMY WAS COMPLETED THE GEL CAP WAS REMOVED AND THE ALEXIS CES BAG WAS FOLDED AND INTRODUCED. THE UTERUS WAS THEN PLACED IN THE BAG AND THE RING OF THE ALEXIS CES WAS PULL THROUGH THE INCISION AND THE SHEATH SHORTENED. THEY THEN ATTEMPTED TO PLACE THE GUARD INTO THE INCISION. AT THIS POINT THEY STRUGGLED TO INSERT THE GUARD INTO THE CENTRE OF THE ALEXIS CES AND INCISION. THEY THEN DECIDED TO UNROLL THE XS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6997027 ↗