MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for STRYKER COBRA 3910-900-093 manufactured by Stryker Endoscopy.
[184482206]
This medical device has the potential to "stick" an employee. The sharp tip that is hidden has historically been classified as a "sharp". Very unsafe device for healthcare personnel. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093840 |
| MDR Report Key | 9853351 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-17 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| 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 | 3 |
| Brand Name | STRYKER COBRA |
| Generic Name | ACCESSORIES, ARTHROSCOPIC |
| Product Code | NBH |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 3910-900-093 |
| Catalog Number | 3910-900-093 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |