MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-10-02 for YASARGIL PERM STD-CLIP STR 7MM FE740K manufactured by Aesculap Ag.
[27362052]
Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[27362053]
Country of complaint: (b)(6). During intra-operative surgery the clip not closed.
Patient Sequence No: 1, Text Type: D, B5
[39848651]
(b)(4). Manufacturing site evaluation: device received in used condition. There were several scratches and points of pressure visible. The jaw parts have a gap and do not close properly. According to the device history record, the clip was delivered with a closing force of 146 grams. The current condition of the device does not allow testing of the closing force. The device quality and manufacturing records were reviewed and found to be according to specification valid at the time of production. No similar incidents have been reported for products of this batch. Based on the information available, the root cause of the failure is user related. It is possible that incorrect application forceps were used. These products are inspected 100% during manufacture; product being delivered in this condition can be excluded. Corrective/preventive action: not applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00847 |
| MDR Report Key | 5123861 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-02 |
| Date of Report | 2016-03-07 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-17 |
| Date Added to Maude | 2015-10-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. 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 |
| 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 PERM STD-CLIP STR 7MM |
| Generic Name | YASARGIL PHYNOX ANEURYSM CLIPS P |
| Product Code | HCH |
| Date Received | 2015-10-02 |
| Model Number | FE740K |
| Catalog Number | FE740K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-02 |