NA 7204863Recalls & reported problems

Smith & Nephew, Inc. · CANNULA OUTFLOW 3MM · Class 1

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 03596010250551), received between Jul 1, 2024 and Jul 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Corroded” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Corroded1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionJul 1, 2024Corroded; Corroded
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THERE WERE FIFTEEN (15) CANNULAS THAT WERE RUSTED AND PITTED. THE PROCEDURE WAS CANCELLED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19651659 ↗

Device details

UDI-DI	`03596010250551`
Brand	NA
Model	7204863
Company	Smith & Nephew, Inc.
Product code	KIJ · INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Rigid endoscopic cannula, reusable

A rigid, single-lumen device intended to be used during endoscopy to provide cannulation for the instillation or aspiration of fluid to/from a targeted area of the body (e.g., introduction of drug solutions, a contrast medium or other kinds of fluid/solution into a body cavity for diagnosis and treatment) or for the introduction/accommodation of another device. It will typically be made of high-grade stainless steel and/or other durable materials. This is a reusable device.

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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.

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