InjuryFGB

E-LINE

Received May 29, 2026 · Event occurred Mar 30, 2026

Report 1418479-2026-00003 · MDR key 25333395

Device

Generic name

Ureterorenoscope 5° 6.5/8.5fr Wl 430mm

Manufacturer

Richard Wolf Medical Instruments Corp.

Model number

8708518

Catalog number

8708.518

Product problems

Material Fragmentation

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

MDR REPORT KEY: (B)(4).

Description of Event or Problem

RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A VOLUNTARY MEDWATCH REPORT, MW5187188, DATED 15/MAY/2026, REGARDING AN ISSUE WITH A URETERORENOSCOPE 5° 6.5/8.5FR WL 430MM, PART ID: 8708.518, SN# (B)(6). ACCORDING TO THE REPORT, A CLEANING BRUSH FRAGMENT WAS FOUND IN A PATIENT'S URETER AFTER PASSING A BASKET THROUGH THE URETEROSCOPE DURING AN URETEROSCOPY PROCEDURE. THE BRUSH FRAGMENT WAS IMMEDIATELY REMOVED. THE SURGERY WAS COMPLETED AND THE PATIENT'S RECOVERY WAS CONSISTENT WITH NORMAL POST-PROCEDURE RECOVERY. ADDITIONALLY, THE FACILITY REPORTED THAT THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 30 MINUTES WHILE A REPLACEMENT DEVICE WAS BEING PROCURED.