E-LINE 8702524Recalls & reported problems
Richard Wolf GmbH · URETERORENOSCOPE 5° 6/7.5FR WL 430MM semi-rigid, with lateral ocular lens, working channel 1x4 (2x2.2)Fr, atraumatic distal tip, TL 599mm, fiber image carrier · 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 04055207020012), received between Feb 3, 2021 and Feb 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Poor Quality Image1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED TO RICHARD WOLF GMBH. "DURING THE FIRST TEST, THE DOCTOR AND THE BIOMEDICAL ENGINEERS CAN SEE THAT THE VISION OF THE URETERO RENOSCOPE IS BAD, THE IMAGE IS BLURRED .THE TREATMENT WAS DELAYED BY THIS INCIDENT OR HAD TO BE DISCONTINUED BECAUSE NO OTHER URETHOSCOPE WAS AVAILABLE. THERE WAS NO RISK TO THE PATIENT OR HEALTH.."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13455526 ↗MalfunctionFeb 3, 2021Break; Break
FOLLOW UP # 1 IS INTENDED TO REPORT THE COMPLAINT INVESTIGATION AND DEVICE EVALUATION.
Patient problems: Insufficient Information
MAUDE report 11273224 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.