CUTTING ELECTRODE BIPOLAR 24-26 FR 12/30 DEGREE
Received Mar 2, 2018 · Event occurred Feb 17, 2018
Report 9611102-2018-00002 · MDR key 7311124
Device
Generic name
Electrode
Manufacturer
Richard Wolf GmbhModel number
46222513Catalog number
46222513
Lot number
4500224068
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
45 YR
- Foreign Body In Patient
- Device Embedded In Tissue or Plaque
- Foreign Body In Patient
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
ACTUAL DEVICE IS NOT RETURNED YET. INVESTIGATION IS CURRENTLY IN PROCESS. (B)(4) CONSIDERS THIS REPORT OPEN, FOLLOW-UP REPORT TO BE SUBMITTED ONCE INVESTIGATION IS COMPLETE. (B)(4).
Description of Event or Problem
DURING THE USE, THE WIRE LOOP ELECTRODE DETACHED AND REMAINED IN THE UTERUS OF THE PATIENT. SECOND ELECTRODE WAS USED AND DETACHED AND REMAINED IN UTERUS. TWO MDRS TO BE SUBMITTED: 9611102-2018-00002, 9611102-2018-00003.
Additional Manufacturer Narrative
(B)(4). AN INVESTIGATION WAS UNABLE TO BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY, BUT NO RESPONSE WAS PROVIDED. RICHARD WOLF GMBH (RWGMBH) CONSIDERS THIS MATTER CLOSED. IN THE EVENT RWGMBH RECEIVES ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA.
Description of Event or Problem
FOLLOW UP REPORT TO PROVIDE ADDITIONAL INFORMATION TO FDA.