Alexis Contained Extraction System with Kii Balloon Blunt Tip System GTK14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20607915137070), received between Mar 14, 2023 and Jan 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 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.

• MalfunctionJan 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: VAGINAL ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: HOSPITAL NAME: DR. [NAME]. "THE SURGEON SOUGHT TO UTILIZE THE ALEXIS CES FOR SPECIMEN EXTRACTION VIA THE VAGINAL CANAL. FOLLOWING THE RESECTION OF THE UTERUS, THE ALEXIS CES WAS INSERTED THROUGH THE VAGINA INTO THE ABDOMINAL CAVITY. THE VAGINA WAS THEN CLOSED WITH A PAD TO FACILITATE INSUFFLATION AND TO SECURE THE SPECIMEN WITHIN THE BAG. THE SURGEON PROCEEDED TO PULL ON THE ALEXIS CES THREAD IN AN ATTEMPT TO EXTRACT THE SPECIMEN. HOWEVER, DUE TO THE SIZE OF THE SPECIMEN, MANUAL MORCELLATION WAS INITIATED TO REDUCE ITS SIZE." "DESPITE HIS EFFORTS, THE SPECIMEN REMAINED SOMEWHAT LARGE, PROMPTING THE SURGEON TO APPLY INCREASED FORCE TO REMOVE IT. AFTER SEVERAL MINUTES OF STRONG PULLING, THE BAG BECAME TORN ALONG THE SEAM. THE SURGEON WAS ABLE TO RETRIEVE THE SPECIMEN BY SECURING IT WITH AN OPEN INSTRUMENT AND CONTINUED PULLING UNTIL IT WAS SUCCESSFULLY REMOVED. THE SURGEON ACKNOWLEDGED THAT THE FORCE APPLIED IN AN ATTEMPT TO EXTRACT THE SPECIMEN CONTRIBUTED TO THE RUPTURE OF THE BAG, BUT I CHOSE TO SHARE THIS INCIDENT FOR YOUR INFORMATION AND REVIEW." INTERVENTION: THE SURGEON WAS ABLE TO RETRIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270024 ↗
• MalfunctionMay 2, 2023Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  PROCEDURE PERFORMED: HYSTERECTOMY EVENT DESCRIPTION: ACCORDING TO THE SURGEON, POTENTIALLY DURING THE MANUAL MORCELLATION STAGE OF THE PROCEDURE. APPLIED MEDICAL REP NOT PRESENT DURING CASE. DURING A ROBOTIC CASE, THE BAG WAS DEPLOYED INSIDE THE PATIENT, THE BAG OPENED UP, SURGEON COMMENTED THAT VISION OF ROBOTIC INSTRUMENTS MAY HAVE BEEN OBSCURED AT THE STAGE BY THE BAG THE UTERUS AND TUBES WERE PLACED INSIDE THE BAG, A PHOTO WAS CAPTURED AT THIS TIME AND ALL APPEARED NORMAL. MANUAL MORCELLATION TOOK PLACE AND THE SURGEON NOTICED FATTY TISSUE AND BRIGHT RED BLOOD. SURGEON THEN TOOK THE HASSAN PORT ROBOT ARMS OFF, TOOK OUT SPECIMEN, RE-ESTABLISHED PNEUMO, WENT BACK TO THE CONSOLE AND CALLED FOR THE ASSISTANCE OF A GENERAL SURGEON TO REPAIR THE MESENTERIC VESSEL WHICH HAD BEEN CUT. SURGEON NOTICED THE BAG HAD BEEN CUT. MESENTERIC VESSEL HAD BEEN CUT REQUIRING REPAIR AND SUBSEQUENT 2 UNITS OF BLOOD GIVEN POST SURGERY. PATIENT ALSO COMPLAINING OF UPSET STOMACH AND IS BEING MONITORED BY GENERAL SURGEON WHO WAS CALLED IN TO ASSIST. DEVICE REMOVED AND SURGICAL INTERVENTION TO REPAIR TISSUE DAMAGE. OTHER INSTRUMENTS USED WHEN THE COMPLAINT EVENT OCCURRED: [NAME] ROBOT, ROBOTIC PORTS AND S

  Patient problems: Laceration(s)

  MAUDE report 16857250 ↗
• MalfunctionMar 14, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  NAME OF PROCEDURE BEING PERFORMED. NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT. "ISSUE: SURGEON ASKED FOR A STERILE DISPOSABLE SUPPLY. ORIENTEE RN OPENED PRODUCT. PRODUCT WAS NOT FACTORY SEALED ON ONE EDGE. SURG TECH ACCEPTED PRODUCT WITHOUT KNOWLEDGE OF UNSEALED. SHE CHANGED GLOVES WHEN ISSUE DISCOVERED, PRODUCT NOT PUT ON STERILE FIELD." PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION. NA (BEFORE USE). PATIENT STATUS. NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540124 ↗