n.a. 11303BNXRecalls & reported problems

Karl Storz GmbH & Co. KG · Flex. Intubation Video Endoscope 5.5x65 · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551421598), received between Mar 23, 2020 and Feb 9, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

Material Fragmentation1
No Display/Image1

Patient problems

Insufficient Information1
Patient Problem/Medical Problem1

Recent adverse event reports

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

InjuryFeb 9, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT PIECES OF THE SHEATH OF THE ENDOSCOPE WERE FOUND IN THE PATIENT'S TRACHEA, REMOVAL WAS REQUIRED USING FORCEPS. THE SHEATH OF THE DEVICE DIDN'T SEEM TO HAVE INTEGRITY ISSUES WHEN EXAMINED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16336377 ↗
MalfunctionMar 23, 2020No Display/Image
PER THE FACTORY IN (B)(6), ALLEGEDLY THERE WAS AN EVENT THAT AN EMERGENCY VIDEO BRONCHOSCOPY WAS BEING PERFORMED DUE TO OBSTRUCTED AIRWAYS (ACUTE BLEEDING). THE SCREEN WENT BLACK/ FAILED DURING THE EXAMINATION. A REPLACEMENT HAD TO BE FOUND PROMPTLY. REPLACEMENT OF THE MEDICAL DEVICE WAS DONE. THE COAGEL WAS SUCKED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 9869246 ↗

Device details

UDI-DI	`04048551421598`
Brand	n.a.
Model	11303BNX
Company	Karl Storz GmbH & Co. KG
Product code	CAL · LARYNGOSCOPE, NON-RIGID
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	Mar 6, 2025

Device type (GMDN): Flexible intubation laryngoscope, video, reusable

An endoscope with a flexible inserted portion intended for the visual examination of the trachea, and to assist the entry and positioning of an airway tube, typically an endotracheal (ET) tube, to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is thin and long to facilitate endoscope entry and the intubation procedure. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. It is typically used during difficult and non-difficult intubation procedures when maintaining an airway open. This is a reusable device.

Other LARYNGOSCOPE, NON-RIGID devices

n.a. 091361-06
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID
10 reports
NA 091361-01
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID
2 reports
C-MAC 11301BNX
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID
2 reports
n.a. 11301BN1
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID
2 reports
n.a. 11302BD2
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, NON-RIGID
1 report

All LARYNGOSCOPE, NON-RIGID 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.

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