MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for PIRANHA SUCTION PUMP 2208001 manufactured by Richard Wolf Gmbh.
[145526108]
A full investigation is currently not possible since the actual device was not returned to richard wolf (b)(4). The institution was contacted for further information. Richard wolf (b)(4) considers this case open and as soon as additional information is available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145526109]
On (b)(6) 2019, an incident occured during surgery at the (b)(6) hospital. The device in question is: irrigator/ aspirator, ref: model piranha 2208 and serial number: (b)(4). The problem is: "after complete enucleation of the prostate, fragmentation was impossible despite testing and replacing all devices ( leakage in the vacuum circuit). The resection mode had to be changed and the operation extended by 3h 30 min. A technician then intervene and the collection container attached to the vacuum cleaner was replaced by a larger one. Since this intervention, the problem has not occured again. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2019-00002 |
| MDR Report Key | 8608608 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2016-02-03 |
| Date Added to Maude | 2019-05-14 |
| 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 BIEDERMAN |
| 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 | PIRANHA SUCTION PUMP |
| Generic Name | PIRANHA SUCTION PUMP |
| Product Code | BTA |
| Date Received | 2019-05-14 |
| Model Number | 2208001 |
| Catalog Number | 2208001 |
| 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 | 2019-05-14 |