MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-03-12 for YASARGIL TI PERM STD-CLIP STR 11MM FT760T manufactured by Aesculap Ag & Co. Kg.
[4407546]
Country of complaint: (b)(6). Clips slipped out 3-4 days post surgery. Revision surgery is necessary due to the slipped clip.
Patient Sequence No: 1, Text Type: D, B5
[11806466]
U. S. Reporting agent notified on (b)(4) 2014. Manufacturing site eval: jaw is no longer opaque and no longer closes completely. Complete surface is severely scratched. Various pressure marks in the shank and spring range. Significant closing force drop of 173 g to 145g. Conclusion: the scratched surface and the pressure marks indicate a multiple use. The pressure marks in the shank suggest that the clip was slanted in the applying forceps. Improper treatment has caused the overloading of the clip and thus the spring and the clamping force is adversely affected. Such is delivery state can be ruled out at 100%.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00130 |
| MDR Report Key | 3845507 |
| Report Source | 01,07 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-01-24 |
| Date Mfgr Received | 2014-01-29 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-06-20 |
| 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 | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| 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 PERM STD-CLIP STR 11MM |
| Product Code | HCH |
| Date Received | 2014-03-12 |
| Model Number | FT760T |
| Catalog Number | FT760T |
| Lot Number | 51909695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN DE 78532 DE 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-12 |