MalfunctionFBO

26 FR FIXED INNER TUBE W/CERAMIC INSULATION SL CF RESECTOSCOPE SHEATHS

Received Mar 6, 2023 · Event occurred Feb 27, 2023

Report MW5115530 · MDR key 16502939

Device

Generic name

Cystourethroscope

Manufacturer

Karl Storz Endoscopy-america, Inc.

Catalog number

27040SD

Lot number

"AD"

Product problems

Break

Patient

56 YR · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A 56 Y/O MALE WAS UNDERGOING CYSTOSCOPY BILATERAL RETROGRADE PYELOGRAM WITH RADIOGRAPHIC INTERPRETATION. TRANSURETHRAL RESECTION BLADDER TUMOR ON (B)(6) 2023 WHILE USING THE RESECTOSCOPE, A PIECE AT THE TOP OF THE SCOPE BROKE OFF. THE PIECE WAS SEEN IN THE BLADDER AND RETRIEVED WITH A STENT GRASP.