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 2019-04-22 for YASARGIL TI TEMP STD-CLIP STR 9MM FT250T manufactured by Aesculap Ag.
[144971783]
(b)(4). Manufacturing site evaluation: investigation- the product arrived in a decontaminated condition and was available for investigation. The jaw was visibly open. We found different labeling between the primary and secondary sterile packaging. We also detected an opened jaw. Additionally, we discovered traces of usage, grooves and quirks. Furthermore we found unknown deposits. Batch history review - the device quality and manufacturing history records have been checked for the lot and found to be according to the specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause - the root cause of the problem is most probably usage related. Rationale - according to the quality standard and the manufacturing files a production error and a material defect can be excluded. Since these clips are subject to a 100% inspection of surface, geometry and closing force, a delivery condition with poor geometry is excluded. Investigations lead also to the assumption that the opened jaw, quirks and grooves were caused by an improper handling. There is the possibility for an incorrect gripping with the applying forceps and was thus opened too wide when opening with the forceps, or were caused by using an applier forceps from other manufacturers. Therefore, there is a restriction of the functionality and the possibility of a changing of the closing force. The factory-set closing force could not be checked because the clip was no longer in its delivery state. The clip had not been distributed in this condition. The clips should not have been used with the described damages and failures. We assume that the secondary sterile packaging comes from another used clip. Furthermore, according to the instructions for use (ifu) the following points and cautions must be observed: damage to the clip due to incorrect handling can cause restriction of the functionality and changing of the closing force. Only remove and apply with the appropriate aesculap applying clips for aneurysm clips. Discard clips that appear changed or show signs of damage (e. G. Incorrect position of the jaws, bent parts, or a changed closing force or discolorations). 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. Carefully grip using the aesculap applying forceps for aneurysm clips and remove - ensure that the clip is not incorrectly gripped. Do not use damaged clips. To avoid damage to the aneurysm clips, always treat the clip with appropriate care.
Patient Sequence No: 1, Text Type: N, H10
[144971784]
It was reported that there was an issue with the yasargil clip. During an unspecified procedure, it was noted that the clip did not close properly. When viewing under the microscope, the clip could not be closed tightly and was not implanted. It was removed from the field and replaced with another device. The operation was continued and there was no patient injury. Additional information was not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00272 |
| MDR Report Key | 8537920 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date Facility Aware | 2019-04-12 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2019-04-22 |
| 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 | 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 TI TEMP STD-CLIP STR 9MM |
| Generic Name | CEREBRO VASCULAR CLIPS |
| Product Code | HCH |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-04-11 |
| Model Number | FT250T |
| Catalog Number | FT250T |
| Lot Number | 52466844 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-22 |