HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
Received Jul 16, 2026 · Event occurred Jul 3, 2026
Report 3007960282-2026-00135 · MDR key 25841910
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22702SLot number
1000244267
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHEN PERFORMING A THERAPEUTIC CYSTOLITHOLAPAXY AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE LOOP ON THE ELECTRODE DETACHED AND FELL INTO THE PATIENT'S BLADDER. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THE SURGEON FELT THE ELECTRODE WAS LIKELY FLUSHED OUT WITH IRRIGATION, BUT THIS WAS NOT VISUALLY CONFIRMED. AN ADDITIONAL COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE TO ENSURE THERE WERE NO FRAGMENTS OF THE DEVICE IN THE PATIENT. THE EVENT RESULTED IN A SLIGHT DELAY OF ABOUT TEN MINUTES IN THE PROCEDURE WHILE SEARCHING FOR THE ELECTRODE. THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE AND THERE WAS NO EFFECT ON THE OUTCOME OF THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.