MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-11 for MYOMA SCREWS 615-210 manufactured by Integra-jaret Instruments.
[15095722]
Corkscrew end of laparoscopic instrument broke free in uterus intraoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028074 |
| MDR Report Key | 2875397 |
| Date Received | 2012-12-11 |
| Date of Report | 2012-12-03 |
| Date of Event | 2012-11-15 |
| Date Added to Maude | 2012-12-18 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOMA SCREWS |
| Generic Name | NONE |
| Product Code | HHO |
| Date Received | 2012-12-11 |
| Model Number | 615-210 |
| Lot Number | 54557 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA-JARET INSTRUMENTS |
| Manufacturer Address | 311 ENTERPRISE DR. PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-11 |