MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-07 for RHINOFORCE II manufactured by Karl Storz.
[77311270]
Surgeon using rhinoforce ii and after procedure found piece of instrument missing. X-ray taken showed 2mm metalic foreign body. Patient had to return to or for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070253 |
| MDR Report Key | 6629473 |
| Date Received | 2017-06-07 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-06-01 |
| Date Added to Maude | 2017-06-09 |
| 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 | RHINOFORCE II |
| Generic Name | FORCEP ENT |
| Product Code | KAE |
| Date Received | 2017-06-07 |
| Lot Number | GE 152 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-06-07 |