Avalign VM46-9151Recalls & reported problems

Avalign Technologies, Inc. · Right Angle Electrode · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190776005627), received between Jan 9, 2024 and Jan 9, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Overheating of Device” (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.

Reports received per month

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

Most reported problems

Device problems

Overheating of Device1

Patient problems

Superficial (First Degree) Burn1

Recent adverse event reports

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

InjuryJan 9, 2024Overheating of Device; Overheating of Device
LIVER TISSUE WAS GETTING BURNED FROM THE INSULATION.
Patient problems: Superficial (First Degree) Burn
MAUDE report 18479677 ↗

Device details

UDI-DI	`00190776005627`
Brand	Avalign
Model	VM46-9151
Company	Avalign Technologies, Inc.
Product code	GEI · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Class	Class 2
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	Jul 6, 2023

Device type (GMDN): Endoscopic electrosurgical electrode, monopolar, reusable

An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.

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