inforMED
MalfunctionFAS

BALL TIP ELECTRODE FOR RIGID CYSTOSCOPES

Received Apr 6, 2021 · Event occurred Mar 31, 2021

Report 11618526 · MDR key 11618526

Device

Generic name

Electrode, Electrosurgical, Active, Urological

Model number

25910-06

Catalog number

RET107K

Lot number

1028468

Product problems

  • Component Missing

Patient

23360 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

UROLOGIST USING BUGBY BALL TIP ELECTRODE. WHEN HE REMOVED IT FROM THE PATIENT, HE NOTICED THE BALL TIP WAS MISSING. UPON INSPECTION, THE SURGEON LOCATED THE BALL TIP ADHERED TO THE BLADDER. HE WAS ABLE TO RETRIEVE THE BALL TIP WITH NO HARM TO THE PATIENT.