n.a. 839310NRecalls & reported problems

Karl Storz GmbH & Co. KG · Insulated Suction Cannula, 3 mm · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551207727), received between Sep 19, 2024 and Sep 19, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Excessive Heating” (2 reports).

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

Excessive Heating2
Temperature Problem1

Patient problems

Burn(s)2

Recent adverse event reports

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

InjurySep 19, 2024Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating
IT WAS REPORTED THAT AN ALLEGED CASE OF A DIATHERMY BURN SUSTAINED BY A PATIENT DURING SURGERY ON (B)(6) 2024.
Patient problems: Burn(s)
MAUDE report 20258435 ↗
InjurySep 19, 2024Excessive Heating; Excessive Heating
IT WAS REPORTED THAT AN ALLEGED CASE OF A DIATHERMY BURN SUSTAINED BY A PATIENT DURING SURGERY ON (B)(6) 2024.
Patient problems: Burn(s)
MAUDE report 20258327 ↗

Device details

UDI-DI	`04048551207727`
Brand	n.a.
Model	839310N
Company	Karl Storz GmbH & Co. KG
Product code	EOB · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
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	Oct 21, 2024

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.