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 PERM MINI-CLIP CVD 3.9MM FE714K manufactured by Aesculap Ag & Co. Kg.
[4405969]
Country of complaint: (b)(6). The clips have been implanted and withdrawn during the same operation. Two clips remain in open position during the withdraw.
Patient Sequence No: 1, Text Type: D, B5
[11960393]
Us reporting agent notified on (b)(6) 2014. Mfr site eval: no traces of wrong use (wrong forceps) could be determined on the clips' surface. All permanent clips are tested regarding their closing force during production. The date of the affected batch was reviewed and found to be fully according to the specs. There are no hints for material or product deviations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00127 |
| MDR Report Key | 3844791 |
| Report Source | 01,07 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-03-05 |
| Date Mfgr Received | 2013-12-03 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2014-06-19 |
| 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 53042 |
| Manufacturer Country | US |
| Manufacturer Postal | 53042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG & CO. KG |
| Manufacturer Street | OP 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 PERM MINI-CLIP CVD 3.9MM |
| Product Code | HCH |
| Date Received | 2014-03-12 |
| Model Number | FE714K |
| Catalog Number | FE714K |
| Lot Number | 51456616 |
| 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 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-12 |