MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-02-03 for AVM MICROCLIP PHYNOX STRAIGHT 4MM FE904K manufactured by Aesculap Ag & Co. Kg.
[15960509]
Country of complaint: (b)(6). Can't grasp the vessel. Operation time delay < 15 min. Surgeon had to use suture technique replace aneurysm clip. Attempted to use additional clip, product number fe903k; same situation occurred. See medwatch 2916714-2015-00059.
Patient Sequence No: 1, Text Type: D, B5
[16063328]
U. S. Agent notified on: (b)(4) 2015. Manufacturing site evaluation: the implant was analyzed microscopically. There are irregular marks on the surface of the clip. The marks on the clip indicates a handling related failure. It is possible that an incorrect instrument for this type of clip was used. Another possible reason for this failure could be the result of an overload situation. No material or manufacturing defects were detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00060 |
| MDR Report Key | 4507190 |
| Report Source | 01,07 |
| Date Received | 2015-02-03 |
| Date of Report | 2015-02-02 |
| Date Mfgr Received | 2014-10-16 |
| Date Added to Maude | 2015-03-11 |
| 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 DR. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG & CO KG |
| Manufacturer Street | P.O. 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 | AVM MICROCLIP PHYNOX STRAIGHT 4MM |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2015-02-03 |
| Model Number | FE904K |
| Catalog Number | FE904K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-03 |