BIPOLAR CUTTING LOOP ELECTRODE, ROUND
Received Dec 12, 2011 · Event occurred Oct 17, 2011
Report 1418479-2011-00022 · MDR key 2418090
Device
Generic name
Bipolar Cutting Electrode
Manufacturer
Richard Wolf Medical Instruments Corp.Model number
4622.1313Catalog number
4622.1313
Product problems
- Break
- Detachment Of Device Component
Patient
29 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE FOLLOWING IS REPORTED TO RWMIC: EVENT DESCRIPTION: DURING THE PROCEDURE, THE BIPOLAR WOLF RESECTOSCOPE 26 FRENCH LOOP ELECTRODE BROKE OFF INSIDE THE UTERUS. MD, USING ANOTHER RESECTOSCOPE WAS ABLE TO RETRIEVE THE SMALL LOOP THAT HAD BROKEN OFF IN THE UTERINE CAVITY, WITHOUT INJURY TO THE PT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? HYSTEROSCOPIC MYOMECTOMY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).
Additional Manufacturer Narrative
DEVICE EVALUATED BY MFR: RA NUMBER WAS PROVIDED TO FACILITY, DEVICE HAS NOT BEEN RECEIVED AS OF (B)(4) 2011. SUSPECT MEDICAL DEVICE: PART NUMBER WAS ORIGINALLY REPORTED AS 4622133, THIS WAS IN ERROR. RWMIC WILL VERIFY PART NUMBER AND LOT NUMBER WHEN ACTUAL PRODUCT IS RECEIVED.