NA 95-3981Recalls & reported problems

SCHÖLLY FIBEROPTIC GmbH · NIR FI CCU Full HD · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250480109083), received between Sep 9, 2026 and Sep 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (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

Temperature Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionSep 10, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724504 ↗
MalfunctionSep 9, 2026Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680786 ↗

Device details

UDI-DI	`04250480109083`
Brand	NA
Model	95-3981
Company	SCHÖLLY FIBEROPTIC GmbH
Product code	FET · Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Nov 7, 2023

Device type (GMDN): Endoscope video camera

An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.