MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-01-10 for WORKING ELEMENT PASSIVE BIPO 8680.225 manufactured by Richard Wolf Gmbh.
[132776893]
Rwmic considers this case open. The user facility and manufacturer will be contacted again in an effort to collect missing information.
Patient Sequence No: 1, Text Type: N, H10
[132776894]
On (b)(6) 2018, richard wolf medical instruments corporation (rwmic) was served with a patient lawsuit involving a "button type bipolar prostate resector and/or electrosurgical generator". On (b)(6) 2016, the patient underwent a procedure described as "cystoscopy with urethral dilation, transurethral resection/ablation of prostate with bipolar". During said procedure, the patient was under general anesthesia and suffered thermal injury to their bladder and urethra. At this time, the involvement of richard wolf products has not been confirmed. However, the following are considered suspect products and mdrs will be submitted for each until the user facility is able to confirm that no richard wolf products were involved: 8680. 225 working element passive bipo 0/12/30 (mdr), 8680. 224 working element passive bipo 0/12/30 (mdr 1418479-2018-00052), 46300223 bivap electrode bipo 22fr 12/30 (mdr 1418479-2018-00053), 46300243 bivap electrode bipo 24-26fr 12/30 (1418479-2018-00054).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2018-00051 |
| MDR Report Key | 8238005 |
| Report Source | OTHER |
| Date Received | 2019-01-10 |
| Date of Report | 2018-12-10 |
| Date of Event | 2016-11-30 |
| Date Facility Aware | 2018-12-10 |
| Report Date | 2019-01-10 |
| Date Reported to FDA | 2019-01-10 |
| Date Reported to Mfgr | 2019-01-10 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2019-01-10 |
| 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. OLIVER EHRLICH |
| 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 | 3 |
| Brand Name | WORKING ELEMENT PASSIVE BIPO |
| Generic Name | WORKING ELEMENT PASSIVE BIPO |
| Product Code | FDC |
| Date Received | 2019-01-10 |
| Model Number | 8680.225 |
| Catalog Number | 8680.225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-10 |