MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-12-04 for 6VT-D PROBE USGETE manufactured by Ge Vingmed Ultrasound As.
[169088811]
(b)(4). Ge healthcare's investigation is on-going at this time.
Patient Sequence No: 1, Text Type: N, H10
[169088812]
A customer reported to ge healthcare that during a te exam the patient's esophagus was pierced by the 6vt-d ultrasound probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610482-2019-00004 |
| MDR Report Key | 9410996 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-12-04 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2019-11-22 |
| Device Manufacturer Date | 2019-01-18 |
| Date Added to Maude | 2019-12-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 6VT-D PROBE |
| Generic Name | 6VT-D ULTRASOUND TRANSDUCER |
| Product Code | ITX |
| Date Received | 2019-12-04 |
| Model Number | USGETE |
| Lot Number | 212706 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE VINGMED ULTRASOUND AS |
| Manufacturer Address | STRANDPROMENADEN 45 HORTEN N-3183 NO N-3183 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-04 |