MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for VALTCHEV VM 4 manufactured by Conkin Surgical Instruments Ltd..
[133320229]
The pt was undergoing a laparoscopic bilateral salpingectomy. The tip of the uterine manipulator (an instrument) broke off inside the pt during use. Dr was able to retrieve the broken tip. No injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083057 |
| MDR Report Key | 8239519 |
| Date Received | 2019-01-10 |
| Date of Event | 2018-12-10 |
| Date Added to Maude | 2019-01-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VALTCHEV |
| Generic Name | INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGY |
| Product Code | KNA |
| Date Received | 2019-01-10 |
| Model Number | VM 4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONKIN SURGICAL INSTRUMENTS LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |