MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-02 for CUTTING ELECTRODE BIPOLAR 24-26 FR 12/30 DEGREE 46222513 manufactured by Richard Wolf Gmbh.
[101708004]
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).
Patient Sequence No: 1, Text Type: N, H10
[101708005]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2018-00002 |
| MDR Report Key | 7311124 |
| Date Received | 2018-03-02 |
| Date of Report | 2018-02-17 |
| Date of Event | 2018-02-17 |
| Date Mfgr Received | 2018-02-17 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2018-03-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. HEIKO SEIDER-BIEDERMANN |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CUTTING ELECTRODE BIPOLAR 24-26 FR 12/30 DEGREE |
| Generic Name | ELECTRODE |
| Product Code | JOS |
| Date Received | 2018-03-02 |
| Model Number | 46222513 |
| Catalog Number | 46222513 |
| Lot Number | 4500224068 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-02 |