GelPOINT® Path Transanal Access Platform CNO12Recalls & reported problems

Applied Medical Resources Corporation · Transanal Access Platform · Class 2

Data updated Oct 16, 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 00607915126742), received between Oct 11, 2016 and Oct 11, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Detachment Of Device Component1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 11, 2016Detachment Of Device Component; Detachment Of Device Component
"DURING PROCEDURE THE SEALGUARD (CLEAR PLASTIC INTERNAL PIECE) DETACHED AND WAS PUSHED THROUGH CANNULA CAUSING LOSS OF PNEUMO. INSTRUMENTS BEING USED WERE ANGLED GRASPERS, ANGLED 10MM 45 DEGREE SCOPE, ANGLE POINT CAUTERY, STRAIGHT GRASPERS AND SUCTION-IRRIGATION. NO HARM TO PATIENT." PATIENT STATUS: "NO HARM TO PATIENT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6018828 ↗

Device details

UDI-DI	`00607915126742`
Brand	GelPOINT® Path Transanal Access Platform
Model	CNO12
Company	Applied Medical Resources Corporation
Product code	FER · Anoscope And Accessories
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Sep 5, 2024

Device type (GMDN): Laparoscopic multi-instrument access port, single-use

A sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. This is a single-use device.

Other Anoscope And Accessories devices

GelPOINT Path Transanal Access Platform CNB11
Applied Medical Resources Corporation · Anoscope And Accessories
4 reports
GelPOINT Path Transanal Access Platform CNB10
Applied Medical Resources Corporation · Anoscope And Accessories
3 reports
GelPOINT® Path Transanal Access Platform CNO11
Applied Medical Resources Corporation · Anoscope And Accessories
2 reports
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope THD Light - Scope LED Large Rectoscope with inflation bulb Sterile
Thd SPA · Anoscope And Accessories
1 report

All Anoscope And Accessories devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page