MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-24 for VOLUSON P8 UKVP8B manufactured by Ge Ultrasound Korea, Ltd..
[146117253]
(b)(4). Ge's investigation has completed and concluded the adverse event was the result of an inherent risk of the procedure.
Patient Sequence No: 1, Text Type: N, H10
[146117254]
It was reported that two patients each were injured on separate dates. This report represents the first patient injury, patient (b)(6). The voluson p8 was used for ultrasound biopsy needle guidance during vivo oocyte retrieval (vor). The ultrasound probe used was an ic9-rs probe (s/n (b)(4)) along with a cook medical immature ovum aspiration needle (g44358) for harvesting oocytes. The patient went home, and later in the day went to an operation room for operative laparoscopy and cauterization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710090-2019-00002 |
| MDR Report Key | 8642032 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-05-14 |
| Device Manufacturer Date | 2018-10-16 |
| Date Added to Maude | 2019-05-24 |
| 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 | JOSEPH TAMBLYN |
| Manufacturer Street | 9900 W INNOVATION DR MAIL DROP: RP-2130 / B4422 |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOLUSON P8 |
| Generic Name | DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
| Product Code | IYN |
| Date Received | 2019-05-24 |
| Model Number | UKVP8B |
| Lot Number | VP8801216 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE ULTRASOUND KOREA, LTD. |
| Manufacturer Address | SEEH10 SEONGNAM-SI 462-807 KS 462-807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-24 |