MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-12-07 for WORKING ELEMENT 8680.205 manufactured by Richard Wolf Gmbh.
[32858853]
Many devices were used during the procedure, suspect devices include: working element - mdr9611102-2015-00010. Cutting electrode - mdr9611102-2015-00011. Bipolar cable (not manufactured by (b)(4), however manufacturer was notified of event). Devices currently in route to manufacturer for evaluation. (b)(4) considers this report open and will sent follow-up at a later date.
Patient Sequence No: 1, Text Type: N, H10
[32858854]
During the final stages of an endoscopic transuretheral electroresection procedure in endovesical hydrosaline solution located at left subtrigonal level, involving homolateral prostatic lobe, a sudden discharge from the electrosurgical unit was noticed. That was followed by haematuria from the outflow channel, with no possibility to fill the bowels with hydrosaline solution anymore. Endoscopic procedure was stopped because laceration of bladder cupola was suspected. Following the immediate intraoperative cystoscopy, proving the laceration of the bladder, abdominal explorative laparotomy was performed, through which a major breaking of bladder cupola was documented, that was sutured. Many device were used during the procedure, suspect devices include: bipolar cable (not manufactured by (b)(4)). Working element - mdr9611102-2015-00010. Cutting electrode - mdr9611102-2015-00011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2015-00010 |
| MDR Report Key | 5272614 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-12-07 |
| Date of Report | 2015-10-30 |
| Date of Event | 2015-10-13 |
| Device Manufacturer Date | 2014-03-14 |
| Date Added to Maude | 2015-12-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. OLIVER EHRLICH |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer Phone | 043351013 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| 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 |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2015-12-07 |
| Model Number | 8680.205 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-07 |