n.a. 152802Recalls & reported problems

Karl Storz GmbH & Co. KG · Ear Loop, size 2, 16 cm · Class 1

Data updated Oct 13, 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 04048551057650), received between Dec 11, 2025 and Dec 11, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or 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. 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

Detachment of Device or Device Component1

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.

MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED NO DEFECT DESCRIPTION WAS PROVIDED FOR THIS CASE. BUT THE TECHNICAL INSPECTION OF THE DEVICE SHOWED THAT 3 LOOPS WERE BROKEN AT THE DISTAL END. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-02295, 9610617-2025-02296.
Patient problems: Insufficient Information
MAUDE report 23783428 ↗

Device details

UDI-DI	`04048551057650`
Brand	n.a.
Model	152802
Company	Karl Storz GmbH & Co. KG
Product code	LRC · INSTRUMENT, ENT MANUAL SURGICAL
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	Oct 5, 2018

Device type (GMDN): Ear snare

A hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device.

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All INSTRUMENT, ENT MANUAL SURGICAL 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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