GelPOINT Path Transanal Access Platform CNB11Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915137922), received between Sep 7, 2022 and Sep 2, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TAMIS. EVENT DESCRIPTION: HOSPITAL NAME: [NAME] "DR WAS INSUFFLATING", "GELPOINT PATH WAS LEAKING FROM THE ACCESS CHANNEL DR HAD TO PRESS THE WHOLE SYSTEM AGAINST THE SKIN AND THE GEL AGAINST THE ACCESS CHANNEL TO PREVENT LEAKING NO INSUFFLATION TOOK PLACE". ADDITIONAL INFORMATION RECEIVED BY FIELD TEAM ON AUGUST 25, 2025 BY EMAIL: PLEASE NOTE THAT WE DID NOT SEE ANY DUCKBILL FALLING. NEITHER INSIDE NOR OUTSIDE THE PATIENT. ALSO, I DON'T THINK THIS WAS THE PROBLEM, SINCE WE TRIED ATTACHING THE INSUFFLATION DIRECTLY TO THE GEL RATHER THAN THE ISB AND TROCAR, IT STILL LEAKED AIR. INTERVENTION: CONTINUED WITH MINIMAL VISION. PATIENT STATUS: GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946492 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TAMIS. EVENT DESCRIPTION: [HOSPITAL]. THIS IS A COMPLAINT FROM THE HOSPITAL; AFTER THE FORCEPS WAS PASSING THE SLEEVE, THE SLEEVE FLANGE CAME OFF AND IT FELL INTO THE ABDOMINAL CAVITY. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. THE FRAGMENT WAS COLLECTED AND PROCEDURE WAS COMPLETED. THE INVESTIGATION REPORT HAS BEEN REQUESTED BY THE HOSPITAL. THIS EVENT UNIT WILL BE RETURNED. INTERVENTION: THE FRAGMENT WAS COLLECTED, AND PROCEDURE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097281 ↗
• MalfunctionOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TAMIS. EVENT DESCRIPTION: [SURGEON'S NAME REDACTED] (SURGEON) WAS USING GELPOINT PATH (TAMIS). HE HAS PERFORMED APPROXIMATELY 40 TAMIS CASES TO DATE. THIS IS THE EMAIL I RECEIVED FROM [NAME REDACTED], THEATRE MANAGER AT [HOSPITAL]. "WE HAD ISSUES WITH THE SHORT TAMIS PORT IN THEATRES TODAY, [SURGEON'S NAME REDACTED] WAS OPERATING, AND ONE ATTACHMENT CAME OFF FROM THE PORT AND WENT INSIDE THE RECTAL AREA OF THE PATIENT AND [SURGEON'S NAME REDACTED] HAD TO LOOK FOR IT TO BRING IT OUT. WE HAVE DONE A DATIX AND KEPT THE EQUIPMENT FOR YOU TO INVESTIGATE IF POSSIBLE AS IT WOULD HAVE BEEN DANGEROUS IF IT GOES INSIDE THE PATIENT AND WE WERE UNABLE TO LOCATE IT OR IF WE DIDN'T REALIZE ITS BEEN MISSING FROM THE PORT BECAUSE IT IS A PLASTIC/RUBBER BIT, IT WOULDN'T HAVE SHOWN IN THE X RAY EITHER I ASSUME." ADDITIONAL INFORMATION RECEIVED FROM FIELD TEAM MEMBER VIA EMAIL ON 18SEPT2023: I SPOKE WITH [NAME REDACTED] ON THURSDAY 14TH SEPTEMBER , WHO WAS THE SCRUB NURSE DURING THE TAMIS CASE. SHE SAID IT WAS A VERY COMPLICATED PROCEDURE, WITH A LARGE AND SPREAD-OUT POLYPS. SHE REPORTED THAT THE CASE WAS VERY BLOODY AND OOZY. SHE EXPLAINED THAT DUE TO THIS, THE PROCEDURE TOOK LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913959 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: TATME (TRANSANAL TOTAL MESORECTAL EXCISION). EVENT DESCRIPTION: THIS IS THE NEW CER INFORMATION FROM [NAME] HOSPITAL ABOUT GEL POINT PATH, CNB11. ONE OF TWO BLACK FRAGMENT FELL OFF TO THE PATIENT BODY CAVITY. THIS HAS ALREADY RETRIEVED ON THE OPERATION AND THE OPERATION WAS SUCCESSFULLY COMPLETED WITHOUT CHANGING OF PRODUCT. THE ANOTHER FRAGMENT WAS FOUND FROM THE INSIDE OF SLEEVE AFTER THE OPERATION. EVENT DESCRIPTION PER CER FORM: A BLACK FRAGMENT WAS FOUND IN THE BODY CAVITY DURING OPERATION OF TATME. THIS FRAGMENT A WAS RETRIEVED BY FORCEPS. THERE IS NO IMPACT TO THE PATIENT AND THE OPERATION HAS COMPLETED WITHOUT REPLACING PRODUCT. AFTER THE OPERATION OF USING THE GEL POINT PATH, THE DR. TOOK OUT THE VALVE FROM THE SLEEVE TO SEARCH FOR THE CAUSE OF THE FRAGMENT. HE FOUND THE MISSING OF THE VALVE AND THERE IS AN ANOTHER FRAGMENT IN THE SLEEVE WHICH CAME OUT AT THE SAME TIME AS THE VALVE. THE REQUEST FROM THE HOSPITAL IS TO INVESTIGATE WHETHER THE FRAGMENTS ARE PART OF PATH AND REPORT THE RESULT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 03JUL2022 VIA EMAIL FROM APPLIED MEDICAL REPRESENTATIVE: PER SURGEON, NO DEBRIS WAS LEFT BEHIND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375317 ↗