MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-03-09 for YASARGIL TI TEMP STD-CLIP STR 7MM FT240T manufactured by Aesculap Ag & Co. Kg.
[5591355]
Country of complaint: (b)(6). When the surgeon tried to release the clip from the forceps, blades of the clip were not closed completely. The surgeon changed the clip to another one, and then the operation was done without problem.
Patient Sequence No: 1, Text Type: D, B5
[13081210]
Manufacturing site evaluation: evaluation on-going at manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00187 |
| MDR Report Key | 4617994 |
| Report Source | 01,07 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-03-06 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-02-06 |
| Date Added to Maude | 2015-05-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG & CO KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL TI TEMP STD-CLIP STR 7MM |
| Product Code | HCH |
| Date Received | 2015-03-09 |
| Model Number | FT240T |
| Catalog Number | FT240T |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-09 |