REUSABLE MONOPOLAR ELECTRODE
Received Mar 16, 2018 · Event occurred Feb 21, 2018
Report 9611102-2018-00004 · MDR key 7347249
Device
Generic name
Monopolar Electrode
Manufacturer
Richard Wolf Germany (rwgmbh)Model number
8416031Catalog number
8416031
Product problems
- Overheating of Device
- Overheating of Device
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
UNABLE TO INVESTIGATION/EVALUATION DUE TO ACTUAL DEVICE NOT BEING RETURNED TO MANUFACTURER AND NO LOT NUMBER SUPPLIED BY USER FACILITY. FACILITY WAS CONTACTED IN AN EFFORT TO GATHER MISSING MEDWATCH INFORMATION, THE DEVICE IN QUESTION AND/OR PHOTOS OR VIDEOS OF THE DEVICE. NO RESPONSE AS OF YET. RICHARD WOLF (B)(4) ((B)(6)) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT (B)(6) RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) SUBMITTING REPORT ON BEHALF OF (B)(4) REPORT ON BEHALF OF (B)(4).
Description of Event or Problem
SUSPECT DEVICE WAS USED ON A TUMOR ON A CHILDS SMALL INTESTINE. THE LOOP COMPLETELY DEGRADED AND WAS NEVER FOUND AGAIN. PROCEDURE WAS COMPLETED.