MalfunctionJOS
HF-RESECTION ELECTRODE
Received Dec 12, 2018 · Event occurred Oct 1, 2018
Report 8154510 · MDR key 8154510
Device
Generic name
Electrode, Electrosurgical, Active
Manufacturer
Olympus Winter & Ibe GmbhLot number
10000024078
Product problems
- Break
Patient
22265 DA
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
WHILE IN SURGERY THE SURGEON REPORTED THE HF-RESECTION ELECTRODE LOOP HAD BROKEN APART. OPERATING ROOM (OR) STAFF OPENED ANOTHER LOOP AND SURGERY WAS CONTINUED. METAL PIECES WERE FLUSHED INTO THE BLADDER WHERE SURGEON REPORTED THAT PATIENT WOULD BE ABLE TO PASS MICROSCOPIC PIECES OF METAL.