MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99,unknown report with the FDA on 2014-10-08 for WORKING ELEMENT 8653.224 manufactured by Richard Wolf Gmbh.
[4980398]
Facility contacted one of richard wolf medical instrument corp (rwmic) sales reps to report that a spark was seen during a procedure to remove a fibroid from pt's uterus. No injury to pt or staff reported.
Patient Sequence No: 1, Text Type: D, B5
[12385583]
An investigation was not completed as the actual device was not returned for investigation as of 10/09/2014. Facility indicated they will not be returning device but will help in providing add'l info and photos. Device history: unk at this time, serial number not given. According to rwmic records, six devices of one lot were purchased 09/2008 and one add'l device purchased 10/2009. Richard wolf considers this matter opened. Once add'l info is received, f/u info will be provided to fda.
Patient Sequence No: 1, Text Type: N, H10
[55724679]
This is a follow up report to change status of this report from open to closed, no new information added. If any additional information is received it will be forwarded to manufacture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2014-00044 |
| MDR Report Key | 4193997 |
| Report Source | 99,UNKNOWN |
| Date Received | 2014-10-08 |
| Date of Report | 2014-09-23 |
| Date of Event | 2014-09-01 |
| Date Facility Aware | 2014-09-25 |
| Report Date | 2014-10-09 |
| Date Reported to FDA | 2014-10-09 |
| Date Reported to Mfgr | 2014-10-09 |
| Date Added to Maude | 2014-10-23 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2014-10-08 |
| Model Number | 8653.224 |
| Catalog Number | 8653.224 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | KNITTLINGEN 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-08 |