AURORA® Surgiscope® AS8/130Recalls & reported problems

Rebound Therapeutics Corporation · AURORA® Surgiscope® System · Class 1

Data updated Oct 18, 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 00850002332131), received between Nov 29, 2023 and Nov 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Excessive Heating1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionNov 29, 2023Excessive Heating; Excessive Heating
A FACILITY REPORTED THAT THE AURORA SURGISCOPE 13CM (AS8/130) WAS USED ON A ICH (INTRACEREBRAL HEMORRHAGE) PROCEDURE WHEN THE SURGEON NOTED A MESSAGE ON THE MONITOR, "CAMERA OVERHEATING". THE SCOPE WAS REMOVED AND THEN REPLACED WITH A NEW 15 MM SCOPE TO CONTINUE THE PROCEDURE. THERE WAS NO DELAY NOR PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18230064 ↗

Device details

UDI-DI	`00850002332131`
Brand	AURORA® Surgiscope®
Model	AS8/130
Company	Rebound Therapeutics Corporation
Product code	GTZ · ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
Class	Class 1
FDA submission	K191861
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 3, 2023

Device type (GMDN): Rigid optical intracranial/spinal endoscope, single-use

An endoscope with a rigid distal portion intended for the visual examination and treatment of the brain (e.g., ventricles, hydrocephalus) and/or spine and contents [e.g., vertebrae, intervertebral discs, spinal cord (myeloscopy)]; it is not dedicated for use in the epidural space (i.e., not a dedicated epiduroscope). Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle; it does not include video imaging capability, however, might be used with a separate video camera for optional video image viewing. This is a single-use 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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