MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for TENACULUM FORCEP 825-215 manufactured by U.s. Surgitech.
[100694571]
Doctor was interpretive morcellating uterus when tip of grasper came off. Doctor was able to locate and remove. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075383 |
| MDR Report Key | 7285680 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-15 |
| Date Added to Maude | 2018-02-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TENACULUM FORCEP |
| Generic Name | TENACULUM FORCEP |
| Product Code | HDC |
| Date Received | 2018-02-20 |
| Model Number | 825-215 |
| Catalog Number | 825-215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | U.S. SURGITECH |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |