inforMED
MalfunctionFBO

INNER TUBE WITH CERAMIC BEAK

Received Apr 13, 2018 · Event occurred Apr 10, 2018

Report 7428297 · MDR key 7428297

Device

Generic name

Cystourethroscope

Model number

27050XA

Catalog number

27050XA

Lot number

SW06

Product problems

  • Break
  • Detachment Of Device Component
  • Crack

Patient

66 YR

  • No Information
  • No Information

Narrative

Description of Event or Problem

PATIENT WAS IN THE OPERATING ROOM (OR) FOR A CYSTOSCOPY AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). INNER SHEATH OF KARL STORZ INSTRUMENT HAD THE TIP COVERED IN PLASTIC. PLASTIC CRACKED AND PIECES OF PLASTIC BROKE OFF INTO THE PATIENT BLADDER. DR. IRRIGATED AND USED GRASPERS TO RETRIEVE THE PIECES OF PLASTIC. HE IRRIGATED THE BLADDER COPIOUSLY AND INSPECTED THE BLADDER THOROUGHLY UNDER VIDEO ENDOSCOPY TO ENSURE NO PIECES WERE LEFT IN THE BLADDER.