MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-06-21 for manufactured by .
[7898203]
Inspecting the instrument visually, we noticed that the jaw part is broken off in the quite thin area of the jaw hinge. The surface of the fracture is rough and uneven. These observations lead us to the assumption, that the jaw part broke off either due to too much force applied to the instrument or any impact. The exact cause for the break cannot be conclusively determined. Since this eval indicates no defect of material, no defect in design or any defect in mfg, we feel that no corrective measure is to be taken on our part.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680515-2006-00004 |
| MDR Report Key | 964895 |
| Report Source | 08 |
| Date Received | 2006-06-21 |
| Date Mfgr Received | 2006-06-09 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2007-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | KANTSTRASSE 33 |
| Manufacturer City | WURMLINGEN 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78573 |
| Manufacturer Phone | 461965760 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | EMH |
| Date Received | 2006-06-21 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 715805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-21 |