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GelPOINT® Path Transanal Access Platform CNO11Recalls & reported problems

Applied Medical Resources Corporation · Transanal Access Platform · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915134440), received between Jul 26, 2019 and Apr 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    NAME OF PROCEDURE BEING PERFORMED: TATME CASE. 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 11717051 ↗
  • MalfunctionJul 26, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: THE PRODUCT DID NOT PASS THE INCOMING INSPECTION OF PO#: (B)(4) BECAUSE OF TORN PACKAGING. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INVOLVED.

    Patient problems: No Patient Involvement

    MAUDE report 8834213 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.