E-LINE 8703524Recalls & reported problems
Richard Wolf GmbH · URETERORENOSCOPE 12° 8/9.8FR WL 430MM semi-rigid, with lateral ocular lens, working channel 1x5 (2x3)Fr, atraumatic distal tip, TL 599mm, fiber image carrier · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207020081), received between Jul 15, 2020 and Jan 3, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
Most reported problems
Device problems
- Material Twisted/Bent2
- No Display/Image2
Patient problems
- Insufficient Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2024No Display/Image; No Display/Image
A DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING A URETERORENOSCOPE 12° 8/9.8FR WL 430MM, PART ID: 8703.524, S/N # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, A PLANNED LITHOTRIPSY COULD NOT BE PERFORMED BECAUSE AN IMAGE FAILURE OCCURRED DURING THE APPLICATION. THE PROCEDURE WAS CANCELLED.
Patient problems: Insufficient Information
MAUDE report 18438631 ↗InjuryJun 30, 2023No Display/Image; Material Twisted/Bent; No Display/Image; Material Twisted/Bent
A DISTRIBUTOR HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A URETERORENOSCOPE 12° 8/9.8FR WL 430MM, PART ID: 8703524, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, DURING A DIAGNOSTIC URETEROSCOPY/URETERORENOSCOPY (URS) EXAMINATION, THE DISTAL END OF THE SCOPE BENT AND AS A RESULT, THE MONITOR FAILED TO DISPLAY THE IMAGE. CONSEQUENTLY, THE PLANNED SURGERY FOR THE LEFT MID URETERAL AREA WAS CANCELLED.
Patient problems: Insufficient Information
MAUDE report 17239921 ↗MalfunctionJul 15, 2020Material Twisted/Bent; Material Twisted/Bent
AT THE REMOVAL OF THE URETERAL STONE ON (B)(6) 2020, THE 8703524 URETERORENOSCOPE 12° 8/9,8CH NL 430MM BENT IN THE LOWER URETER DURING ADVANCEMENT. THE PATIENT HAD A SPLINTED URETER, THE URETER WAS TAUT (BUT NOT TOO TAUT ACCORDING TO HER STATEMENT). THE REMOVED THE URS AFTER SHE HAD NO PICTURE ANYMORE. AN INJURY OF THE PATIENT (E.G. BY TEARING OFF THE URETER, ETC.) WAS NOT VISIBLE ACCORDING TO DR. (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10276316 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.