GelPOINT Path Transanal Access Platform CNB10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915137915), received between Aug 5, 2020 and Apr 6, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionApr 6, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: TAMIS. EVENT DESCRIPTION: THE DOCTOR INFORMED ME COUPLE OF DAYS AFTER HIS SURGERY THAT WHILE PERFORMING A TAMIS CASE USING THE GELPOINT PATH EARLY THIS WEEK; WHICH HE USED SEVERAL TIMES BEFORE; ONE OF THE TROCAR¿S SEAL WAS LOOSE AND PART OF IT WENT INSIDE THE PATIENT. HE DETECTED THE PIECE MISSING AND REMOVED IT AND REPLACED THE TROCAR WITH ANOTHER ONE AND CONTINUED THE SURGERY WITH NO HARM TO THE PATIENT. HE FORGOT TO INFORM THE NURSES IN TIME TO KEEP ALL THE COMPONENTS OF THE GELPOINT PATH OR AT LEAST THE DEFECTED TROCAR, SO THEY DISCARDED IT DIRECTLY AFTER THE SURGERY AS PER THE USUAL PROTOCOL. ADDITIONAL FEEDBACK RECEIVED FROM THE FIELD TEAM VIA EMAIL ON (B)(6) 2026: THE LOT NUMBER: 1552944 IS CORRECT. THE TROCAR¿S SEAL WAS THE PART THAT WAS LOOSE AND DETACHED, WHICH THEN ENTERED INSIDE THE PATIENT. INTERVENTION: HE WAS ABLE TO CONTINUE THE CASE WITH THE SAME ITEM. PATIENT STATUS: NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793961 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NAME OF PROCEDURE BEING PERFORMED: TATME CASE. DESCRIBE EVENT OR PROBLEM: HOSPITAL: [NAME]. GELPOINT POINT PATH WAS USED FOR A TATME CASE. DURING THE CASE, SURGEON TRIED TO REMOVE A GRASPER FROM THE 10MM SLEEVE, IT ALSO DRAGS OUT THE PLASTIC INSTRUMENT GUIDE. A 4TH PIECE WAS INTRODUCED. HALF WAY THROUGH THE SURGERY, THE SURGEON TRIED TO REMOVE THE GRASPER AGAIN FOR CLEANING BUT THE PLASTIC INSTRUMENT GUIDE WAS DRAGGED OUT AGAIN. IN THE END, CIRCULATING NURSE HAD TO OPEN ANOTHER PIECE OF SLEEVES FROM [NAME] (NEW BOX). ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06APR2021 FROM [NAME]: PLASTIC INSTRUMENT GUIDE IS "REFERRING TO THE TROCARS AS PER ATTACHED PICTURE." PHOTO ATTACHED. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: A NEW PIECE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717033 ↗
• MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NAME OF PROCEDURE BEING PERFORMED: TEO. DETAILED DESCRIPTION OF EVENT: HOSPITAL: [NAME] HOSPITAL. THE INNER VALVE OF THE ACCESS CHANNEL FELL OUT BEFORE INSERTING THE GELPOINT PATH INTO THE PATIENT'S RECTUM. USED ANOTHER ACCESS CHANNEL AS REPLACEMENT. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION USED ANOTHER ACCESS CHANNEL AS REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10368355 ↗