MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-02-13 for YASARGIL PERM MINI-CLIP STR NARR 3MM FE680K manufactured by Aesculap Ag.
[137719031]
Manufacturing site evaluation: investigation - no product at hand. Batch history review - no batch number available. Conclusion and root cause - no product was available and therefore it was hardly possible to determine an exact conclusion or root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale - since these clips are subject to a 100% inspection of surface, geometry and closing force, a delivery condition with poor geometry is excluded. There is the possibility for damage due to incorrect handling. Possibly the clip had been removed from the sterile packaging with an application forceps from a competitor. Another reason could be that it was opened too wide with the forceps. Therefore, there is a restriction of the functionality and the possible change of the closing force. If further investigation is required, the product should be provided for examination. The instructions for use (ifu) also mentions points and caution for handling, as mentioned previously. Additional points from the ifu include the following: prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components; do not use the product if it is damaged or defective; immediately discard any damaged products; always treat the aneurysm clips with appropriate care; never open aneurysm clips with your fingers; avoid any manual and/or mechanical manipulation (e. G. With fingers or instruments) of the aneurysm clips.
Patient Sequence No: 1, Text Type: N, H10
[137719032]
Prior to use during a craniotomy on (b)(6) 2019, the cerebrovascular mini clip would not close and hold position. The clip was not used. The incident did not cause or contribute to a serious injury and there was no delay in surgery. Further details on the procedure were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00082 |
| MDR Report Key | 8337123 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-13 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-01-18 |
| Date Facility Aware | 2019-02-27 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-02-13 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NICOLE BROYLES |
| Manufacturer Street | 1 A RAUMANTIE |
| Manufacturer City | HELSINKI MO 00350 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00350 |
| 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 MINI-CLIP STR NARR 3MM |
| Generic Name | CRANIAL IMPLANTS |
| Product Code | HCH |
| Date Received | 2019-02-13 |
| Model Number | FE680K |
| Catalog Number | FE680K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-13 |