MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for RAPTOR GRASPING DEVICE 00711177 manufactured by United State Endoscopy Group, Inc..
[137120735]
Raptor grasping device broke during procedure. Able to retrieve all pieces from device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084083 |
| MDR Report Key | 8343217 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-02-09 |
| Date Added to Maude | 2019-02-15 |
| 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 | RAPTOR GRASPING DEVICE |
| Generic Name | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED |
| Product Code | OCZ |
| Date Received | 2019-02-14 |
| Catalog Number | 00711177 |
| Lot Number | 1820710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATE ENDOSCOPY GROUP, INC. |
| Manufacturer Address | MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-14 |