MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2009-11-18 for KMEDIC SISTRUNK SCISSORS CURVED KM34354 manufactured by Kmedic Europe Gmbh.
[1518078]
Incident reported as: the tip of the scissors broke during surgery. The surgeon located the broken piece. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8339313]
Sample requested but not received yet. Investigation is ongoing and a follow-up report will be issued when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005236665-2009-00008 |
| MDR Report Key | 1547736 |
| Report Source | 01,06,07 |
| Date Received | 2009-11-18 |
| Date of Report | 2009-09-25 |
| Date Mfgr Received | 2009-09-25 |
| Date Added to Maude | 2010-08-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ANGELA BROWN, MANAGER |
| Manufacturer Street | 4024 STIRRUP CREEK DRIVE |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | KMEDIC EUROPE GMBH |
| Manufacturer Street | GAESAECKER 36 |
| Manufacturer City | TUTTLINGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KMEDIC SISTRUNK SCISSORS CURVED |
| Generic Name | CURVED SCISSORS |
| Product Code | HRR |
| Date Received | 2009-11-18 |
| Catalog Number | KM34354 |
| Lot Number | 04/1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KMEDIC EUROPE GMBH |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-18 |