MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-06-05 for YASARGIL APPLYING FORCEPS FOR STANDARD ANEURYSM CLIPS FE584K manufactured by Aesculap Ag & Co. Kg.
[186887]
Neurosurgeon was attempting to place an aneurysm clip on a vessel when the clip applier did not release properly, resulting in a vessel tear and subsequent bleeding. A larger size aneurysm clip was then placed in the same clip applier and successfully placed on vessel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2000-00007 |
| MDR Report Key | 281257 |
| Report Source | 07 |
| Date Received | 2000-06-05 |
| Date of Report | 2000-06-02 |
| Date of Event | 2000-05-01 |
| Date Mfgr Received | 2000-05-02 |
| Date Added to Maude | 2000-06-13 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LIA JONES |
| Manufacturer Street | 1000 GATEWAY BLVD |
| Manufacturer City | SO. SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6506245073 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL APPLYING FORCEPS FOR STANDARD ANEURYSM CLIPS |
| Generic Name | ANEURYSM CLIP APPLIER |
| Product Code | HCI |
| Date Received | 2000-06-05 |
| Model Number | NA |
| Catalog Number | FE584K |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 272209 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | P.O. BOX 40 TUTTLINGEN GM 78501 |
| Baseline Brand Name | YASARGIL APPLYING FORCEPS |
| Baseline Generic Name | ANEURYSM CLIP APPLIER |
| Baseline Model No | NA |
| Baseline Catalog No | FE584K |
| Baseline ID | NA |
| Baseline Device Family | CLIP APPLYING FORCEPS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833651 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-06-05 |