MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for SNOWDEN-PENCER manufactured by Carefusion.
[95527688]
Patient Sequence No: 1, Text Type: N, H10
[95527689]
During endoscopic brow lift surgery, one side of the snowden-pencer endograsper broke off. The broken piece was identified and safely removed in it's entirety. There were no untoward patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7137605 |
| MDR Report Key | 7137605 |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-12-12 |
| Report Date | 2017-12-12 |
| Date Reported to FDA | 2017-12-12 |
| Date Reported to Mfgr | 2017-12-12 |
| Date Added to Maude | 2017-12-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SNOWDEN-PENCER |
| Generic Name | FORCEPS, GENERAL, PLASTIC |
| Product Code | KOG |
| Date Received | 2017-12-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143 |
| Brand Name | SNOWDEN-PENCER |
| Generic Name | FORCEPS, GENERAL, PLASTIC |
| Product Code | GEN |
| Date Received | 2017-12-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-21 |