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 |