Alexis Contained Extraction System with GelPOINT Mini Advanced Access Platform GTM14Recalls & reported problems
Applied Medical Resources Corporation · Kit Includes: GTB14, ALEXIS CONTAINED EXT SYS 5BX CNGL3, GelPOINT Mini ADV ACCESS PLATFORM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20607915137063), received between Mar 13, 2025 and Mar 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: THE ALEXIS CES WAS BEING USED TO MANUALLY MORCELLATE A LARGE UTERUS WEIGHING APPROXIMATELY 890G. AFTER MORCELLATION THE SURGEON PULLED UP ON THE BAG AND IT BURST/TORE ALONG THE TOP PART PROXIMAL TO THE RING. THE EVENT OCCURRED AROUND 4 MONTHS AGO AND IS BEING INFORMED NOW. THE SURGEON DOES NOT REMEMBER THE EXACT DATE. LOT NUMBER OF THE PRODUCT IS NOT AVAILABLE. ADDITIONAL INFORMATION WAS PROVIDED VIA EMAIL BY AMA TERRITORY MANAGER ASSOCIATE ON 12-FEB-2025. "SINCE THE INCIDENT OCCURRED QUITE A FEW MONTHS AGO THE SURGEON COULD NOT QUITE REMEMBER EXACTLY WHICH PRODUCT IT WAS. DR [NAME] QUOTED ¿THE ONE WITH THE LARGER BAG¿ WHICH INDICATES GTM17 HOWEVER, POWERBI SHOWS THAT ONLY GTM14 WAS PURCHASED. THE DEVICE AND PACKAGING HAS SINCE BEEN THROWN OUT SO UNFORTUNATELY, WE CANNOT RETRIEVE THE LOT NUMBER FOR THIS CASE." ADDITIONAL INFORMATION WAS PROVIDED VIA EMAIL BY AMA TERRITORY MANAGER ASSOCIATE ON 19-FEB-2025. "THE SURGEON DOES NOT REMEMBER WHAT EXACT MODEL SHE WAS USING HOWEVER, THERE WAS A PURCHASE OF 3 UNITS OF GTM14 BY [FACILITY] BACK IN Q4 2023. I HAVE REACHED OUT TO HER ROOMS AND AWAITING FOR A REPLY." INTERVENTION: NA PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21601805 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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